VAVE Staff Product Development Engineer

Senior Business Intelligence Analyst

Continuous Improvement Analyst III

Senior Manufacturing Engineer

Senior Manager Channel Sales

Quality Improvement Manager

Senior Quality & Reliability Engineer

QC Lab Sample Coordinator

QE Specialist

Senior Electrical Engineer

Responsibilities: <ul><li>Lead VAVE initiatives to optimize cost, improve product performance, and enhance customer value while maintaining quality and reliability.</li><li>Go beyond traditional VAVE by driving R&amp;D in emerging materials, advanced manufacturing processes, automation, digital technologies, and innovative supplier solutions.</li><li>Collaborate with cross-functional teams, suppliers, and technology centers to identify, assess, and implement value-driven design and process improvements.</li><li>Develop and deploy tools and methods to analyze cost, performance, manufacturability, and sustainability throughout the product lifecycle.</li><li>Build and maintain a pipeline of VAVE projects in partnership with engineering, procurement, operations, and product management.</li><li>Serve as a subject matter expert in cost optimization and value engineering strategies, including advanced sourcing and alternative design concepts.</li><li>Partner with customers, sales, and product managers to gather Voice of Customer (VOC) insights and translate them into engineering solutions.</li><li>Provide technical support for cost-reduction activities, including design validation, troubleshooting, and verification of VAVE solutions.</li><li>Collaborate globally with manufacturing, procurement, and suppliers to ensure compliance with technical, quality, cost, and delivery objectives.</li><li>Introduce breakthrough engineering solutions that leverage new technologies and supplier capabilities to accelerate business growth.</li><li>Application Engineering: Understanding customer requirements and offering sustainable cost-efficient design solutions.</li><li>Engineering Management: Developing technical roadmaps aligned with market trends and effectively communicating them to business units, management, and customers.</li><li>Collaboration: Working efficiently with global teams and cross-functional stakeholders.</li><li>Technical Expertise: Adapting to new skills, futuristic materials, advanced manufacturing processes, automation, digital technologies, and innovative supplier solutions.</li><li>Quality Control: Ensuring accuracy and quality in services, documentation, and engineering outputs.</li></ul> Requirements: <ul><li>Master’s degree in mechanical engineering from premier institution.</li><li>Deep understanding of product, design, materials (metals/plastics properties), processes and manufacturing science/technology.</li><li>Knowledge of manufacturing processes such as machining, molding, stamping, and plating is advantageous.</li><li>Familiarity with material standards and agency approvals for connectors, cables, and cable assemblies.</li><li>Experience in environmental life cycle assessment, circular economy, or product stewardship/compliance.</li><li>Knowledge of ISO/IEC/UL standards related to carbon footprint and emissions reduction in industrial products.&nbsp;</li><li>Minimum of 12 years of experience in Product Development, R&amp;D and VAVE engineering.</li><li>Background in connector design (Power/Industrial/Auto connectors) is a plus.</li><li>Ability to work independently in a highly technical environment.</li><li>Expertise in Design for Cost (DFC), Design for Manufacturing (DFM), and Design for Sustainability (DFS).</li><li>Strong Presentation Skills: Proficiency in PowerPoint and effective communication of technical concepts.</li></ul>

Role Description: <ul><li>The Continuous Improvement EMIA team reports to Operations Automotive EMIA.</li><li>By providing new generation digital solutions to our Operational teams across EMIA, our team creates full transparency and speed in the ongoing digital &amp; lean transformation(s), which will enable all involved functions to leverage data to develop business insights and roadmap updates based upon clearly arranged and understandable data. Due to the extended scope, focusing also on the connecting processes from Supplier(s) to Manufacturing ending at the Customer(s) (internal and external) we will function as ‘the’ differentiator for our Company.</li><li>The Data Scientist Automotive EMIA will report to the Smart Factory Leader Automotive EMIA.&nbsp;</li></ul> Responsibilities:&nbsp; <ul><li>Lead projects and work together with our Automotive EMIA Operations plants, internal (IT, , Corporate Technology, CoE, SC, ..) and external partners in the area of Smart Factory (Applications, ML, AI, DL), aligned with Operations Automotive EMIA Strategy.</li><li>Lead Smart Factory improvement projects (Enhancements) of existing applications together with internal / external supplier and customers (project management) until the level of RTD (Ready To Deploy)</li><li>·Use a combined knowledge of computer science and applications, modelling, statistics, analytics and maths to solve problems.</li><li>Identify and interpret data sources, manage large amounts of data, merge data sources together, ensure consistency of datasets, create visualizations to aid in understanding data.</li><li>Develop, Validate and Deploy (including Training and Coaching of the users) until the level of RTD (Ready To Deploy), Digital Factory Applications, ML models, contributing to waste elimination and efficiency improvements within all Operations functions (Manufacturing, Quality, SC, LOG, ….), this together with our internal and external partners.</li></ul>&nbsp;Requirements: Desired candidate &amp; Qualification <ul><li>Good understanding of a technology driven manufacturing company.</li><li>Knowledge of the core manufacturing technologies: Stamping, Plating, Assembly, Molding.</li><li>Experienced with data visualization tools like PowerBi, Tableau, ThingWorx,..</li><li>Good applied statistics skills, such as distributions, statistical testing, regression, etc.</li><li>Development experience in programming languages R, Python.</li><li>Knowledge, experience in JAVA scripting</li><li>Excellent pattern recognition and predictive modelling skills.</li><li>Excellent understanding of machine learning techniques and algorithms, such as k-NN, Naive Bayes, SVM, Decision Forests, neural networks and deep learning etc.</li><li>Experience in technologies like, Jupyter Notebooks, Numpy, Pandas, Seaborn, Scikit-learn, PyTorch and TensorFlow.</li><li>Exposure to recent developments in Deep Learning, Gen AI, Agentic AI domain.</li><li>Database skills, on-premises and cloud based.</li><li>Experience in AWS is an advantage, functional knowledge of AWS platforms such as Sagemaker, S3, and RedShift.</li><li>Excellent presentation skills in both spoken en written English.</li><li>&nbsp;Excellent and strong communicator</li><li>The ability to translate, explain and bring, complex data science topics to an easy understandable level, speeding up acceptance level in general.</li><li>Bachelor or master’s in data science</li><li>Team player with a solution focused problem-solving mentality.</li><li>Change agent with high Execution level, including training and coaching talents.</li><li>Passioned about the combination of Technology, Data, Analytics and Statistics with link to Quality, Product and Process Engineering</li><li>Inspired by and searching actively for new technologies and methods.</li></ul>

Responsibilities: <ul><li>Facilitate, lead, or coach Kaizen and Kaizen events across the organization.</li><li>Work collaboratively with tool or element owners to implement Continuous Improvement tools.</li><li>Lead and audit Continuous Improvement tools.</li><li>Train teams in Continuous Improvement methodologies, tools, and transformation methods (e.g., 5S, TPM, Value Stream Mapping, VSM-D, CCF, 3P, Lean Manufacturing).</li><li>Facilitate and train teams for transformation Kaizen events in highly impactful areas or production cells.</li><li>Obtain internal certifications such as Novice, Apprentice, and Practitioner level in Continuous Improvement.</li><li>Provide coaching to Novice and Apprentice practitioners.</li><li>Train and coach teams on plant Key Performance Indicators (KPIs).</li><li>Report periodic progress on assigned tools, metrics, and initiatives.</li><li>Conduct capacity analysis and mentor production supervisors on managing line capacity.</li><li>Develop scenarios for capacity planning, including footprint analysis.</li><li>Apply advanced knowledge in line balancing and its implications for realistic planning (cross-training, validations, capacity planning, hiring requirements, etc.).</li></ul> Requirements: Knowledge &amp; Experience <ul><li>Bachelor’s Degree in Industrial Engineering or related field.</li><li>3–5 years of experience in continuous improvement, cost savings, or productivity improvement roles.</li><li>Lean certification required.</li><li>Green Belt or Black Belt certification is desirable.</li><li>Experience in process improvement, Six Sigma, and product/process qualification and validation.</li><li>Bilingual (English/Spanish).</li></ul> Skills <ul><li>Proficiency in Microsoft Office 365.</li><li>Strong skills in Excel (Pivot Tables, Charts, Macros), PowerPoint, MS Project, AutoCAD (or similar), Minitab, and simulation software.</li><li>Knowledge of problem-solving techniques.</li><li>Basic competency in creating dashboards using Power BI.</li><li>Basic knowledge of Power Automate or similar tools.</li><li>Ability to work under pressure with strong communication and teamwork skills.</li><li>Experience influencing all organizational levels to support an Operational Excellence culture.</li></ul>

Responsibilities: <ul><li>Lead a dedicated team of engineers and technicians within the Projects or Manufacturing group.</li><li>Ensure that engineers are fully integrated into the overall project team and production support activities.</li><li>Plan and implement training and development programs for direct reports.</li><li>Complete process design and development projects by training and guiding technicians.</li><li>Provide coaching and mentorship to team members.</li><li>Establish engineering goals and objectives aligned with business plans.</li><li>Identify and implement effective, permanent technical and system solutions to problems.</li><li>Consistently meet customer requirements, performance expectations, and deadlines.</li><li>Prepare product and process reports by collecting, analyzing, and summarizing information and trends.</li><li>Champion compliance with internal systems and processes.</li><li>Identify and develop improvements to enhance Service, Delivery, Quality, and Cost metrics using Lean/Six Sigma methodologies.</li><li>Research advanced process technologies and evaluate potential competitive advantages and cost benefits.</li><li>Lead or guide a portfolio of engineering projects in collaboration with cross-functional teams (e.g., NPI, quality engineering, design assurance, R&amp;D).</li><li>Collaborate with teams to plan, coordinate, and implement activities supporting the successful launch of new products, including make/buy analysis, new process introduction, and more.</li><li>Develop or modify manufacturing processes by studying product requirements and designing, modifying, or testing manufacturing methods and equipment.</li><li>Maintain professional and technical knowledge through workshops, publications, networking, and participation in professional societies.</li><li>Manage external relationships with key technology suppliers.</li><li>Oversee workload distribution among engineers and technicians to meet operational and business priorities.</li></ul>&nbsp;Requirements: Education &amp; Experience <ul><li>Bachelor’s degree or equivalent in an Engineering field with 5–10 years of experience in a demanding high-volume production environment or a high-mix, low-volume environment.</li><li>Experience in medical devices or similar regulated manufacturing and quality systems is essential.</li><li>Proficiency with CAD tools; SolidWorks preferred.</li><li>Experience using Minitab, MS Project, and advanced Excel.</li><li>Demonstrated ability to lead a production-focused team, drive technical problem solving, and manage line setup including equipment acquisition and process development.</li><li>Working knowledge of Lean and/or Six Sigma engineering principles with proven results.</li><li>Statistical knowledge, including data analysis and statistical software (JMP, Minitab, etc.).</li><li>Lean Six Sigma Green Belt certification preferred.</li><li>Excellent communication, planning, and organizational skills.</li><li>Self-motivated with strong decision-making abilities.</li><li>Willingness to work independently and to take on an international assignment of up to 3 months.</li><li>Fluent in English (written and verbal), &gt;80% proficiency.</li></ul>

Role Description:&nbsp;<ul><li>Senior Manager – Customer Service is responsible for continuing to drive transformational customer centric strategies geared around delivering extraordinary customer experiences and driving sales growth for the team, while continuing the transformation of our Customer Care organization to a revenue generation organization through consultative selling. </li><li>The Manager would be also responsible for delivering a level of service &amp; driving unsurpassed growth which builds strong customer relationships to make client the supplier of choice. </li><li>Support Solution Center strategic initiatives and drive operational excellence. Support and mentor fellow team Leaders to meet/exceed organizational goals.</li></ul>&nbsp;Responsibilities:&nbsp;<ul><li>Responsible &amp; Accountable to drive revenue and revenue growth.</li><li>Ensure that customer’s challenges are solved by providing excellent customer experience that exceeds customer expectations.</li><li>Implement processes and methods to eliminate barriers and inhibitors to success on a local level.</li><li>Understands market influencers and conditions.&nbsp;</li><li>Drive/influence our current/future product positioning to gain or re-gain market share.&nbsp;</li><li>Understands key components of a Competitive Landscape: customers’ needs and how you can address those needs; how you compare against your competitors in meeting those needs.&nbsp;</li><li>Drives brand awareness and positioning with our customers and distribution partners (Solutions and capabilities).</li><li>Think strategically and lead multiple teams.</li><li>Mentor and develop team Leaders and nurture an environment where they can excel in their current role.</li><li>Own and be accountable for achieving specific departmental objectives and in meeting both sales and Customer Experience goals of Solution Center India.</li><li>Lead and drive all Global Solution Center strategic initiatives in India.</li><li>Equip your team to develop, enhance and grow customer relationships through lead generation, building an opportunity pipeline, nurturing customers through their buying journey and driving customer loyalty.</li><li>Observe and coach your team in their work activities, providing immediate feedback through coaching discipline and following up to ensure appropriate actions are taken by the team</li><li>Recruit new talent and develop a strong talent bench that will embrace the vision and transform the organization.</li><li>Champion transformation initiatives and positively drive the change initiatives within the team.&nbsp;</li><li>Drive operational excellence and continuous improvement mind-set within your team.</li><li>Grow and nurture your team by providing inclusion and engagement opportunities, as well as developing them for their future careers.&nbsp;</li><li>Liaising effectively with various internal business partners like engineering, planning, and sales to resolve Customer inquiries and requests.</li></ul> Requirements:&nbsp; QUALIFICATIONS &amp; EXPERIENCE&nbsp;<ul><li>Bachelor’s degree in Engineering/Management/Science required, MBA preferred.</li><li>Overall 20+ years of professional experience in a multi-national Sales &amp; Business development role leading Sales operations and/or Customer support, with at least last 10 years of experience in Managerial position leading large teams with good proven track records driving sales, customer satisfaction and developing high performing teams.</li><li>Previous experience working in Corporate Sales and should have managed Channel sales, Distribution, customer support &amp; contact center.</li><li>Proven success record of change management efforts in pre &amp; Post Sales Process, customer Support &amp; Sales functions.</li><li>Proven experience of leading large and multi layered teams</li><li>Strong Skills to Drive Opportunity/leads through system like SFDC.</li><li>Excellent knowledge of management methods and techniques.</li><li>Demonstrated experience in working effectively and directly with all levels of the organization.</li><li>Industry specific experience is a plus.</li><li>Excellent communication skills.</li></ul>&nbsp;COMPETENCIES/SKILLS:&nbsp;<ul><li>Customer ‘centric’ and sales mind-set.</li><li>Business Acumen.</li><li>Consultative Selling experience &amp; skills.</li><li>Ability to lead team spread in different countries within your region.</li><li>Servant Leadership.</li><li>Result oriented.</li><li>Ability to maintain progress on multiple tasks, set priorities, and manage time effectively</li><li>Ability to adapt, be agile and drive change.</li><li>Strong communication (written and verbal), persuasion and interpersonal skills</li><li>Ability to establish strong business relationships with other Business units and cross functional departments.</li><li>Ability to influence without authority</li><li>Collaborative, ability to build strong relationships with cross-functional partners within a global and diverse organization.</li><li>Demonstrate proactive positive attitude and instill the same within the team.</li></ul>&nbsp;KEY PERFORMANCE MEASUREMENTS:&nbsp;<ul><li>Strategy, Execution and Talent (SET).</li><li>Employee Engagement.</li><li>Revenue &amp; New Customer Acquisition.</li><li>Customer Effort Score.</li><li>Efficiency/Productivity Improvement.</li></ul>&nbsp;MOTIVATIONAL/CULTURAL FIT&nbsp;<ul><li>Be a coach.</li><li>Building Effective teams.</li><li>Managing and Measuring Work.</li><li>Self-Motivated.</li><li>SET: Strategy, Execution, Talent (for managers).</li><li>Values: Integrity, Accountability, Inclusion, teamwork, Innovation.</li></ul>

Role Information: <ul><li>The Quality Improvement Manager is responsible to drive and support improvement activities and convergent Problem-Solving competencies within AUT ASEAN, leveraging scalable methodologies and digital tools while unleashing people’s talent.</li><li>Working in collaboration with production plant at Gateway Thailand towards waste reduction and improving Incidents on our customer base.&nbsp;</li><li>She/he is the Leader in ASEAN Problem Solving Committee and leads cross functional teams to solve complex and difficult manufacturing and quality problems.</li><li>She/he contributes to the project selection that will have the highest impact on plant metrics.</li><li>She/he coaches plant problem solvers and ensures their development</li></ul> Responsibilities: <ul><li>Leader in ASEAN Problem Solving (PS) Committee.</li><li>Organize regular meeting review status &amp; planning.</li><li>Promote PS culture throughout the Plant and ASEAN at all levels.</li><li>Promote the selection of the projects that will have the highest impact on plant metrics (eg. CoPQ) and manage all PS projects including PS initiatives from Line QRM escalation to VSM/Plant Level.</li><li>Support production improvement process through PS projects.</li><li>Lead cross-functional team to apply diligently a structured problem-solving methodology that best fits the situation (Shainin, SPS, Six Sigma or other equivalent methods as described by the Shifting Gears)</li><li>Follow up all PS projects with project owner and provide coaching to ensure PS methodologies are correctly applied.</li><li>Regular project coaching with PS Master from Global, and follow-up to project closure and realize saving.</li><li>Proactively anticipate roadblocks to find solutions and escalate when needed.</li><li>Report out project progress, people development and savings to PS Committee and Management.</li><li>Tabulate and manage Plant/ASEAN people PS skill matrix and identify training needs, plan &amp; execution.</li><li>Coach, Develop and Expand local Problem Solver Practitioners.</li><li>Represent ASEAN in PS matter and report status to regional and global level.</li><li>Alignment with AP and Global PS leaders for new PS initiatives and execution.</li><li>Any other assignments as delegated by reporting Manager.</li></ul> Requirements: <ul><li>Engineering degree (Mechanical or Electrical Engineering).</li><li>Strong understanding of 6 Sigma tools and Minitab usage.</li><li>Strong understanding of engineering fundamentals and product design</li><li>Experience in taking project using structured problem-solving methodology (Shainin Red-X, 6 Sigma, etc).</li><li>Experience in coaching and training.</li></ul> Specific Requirements(Mandatory): <ul><li>Certified Red X Master or Master Candidate (ability to coach) or Kepner-Tregoe.</li><li>Strong understanding of 6 Sigma tools and Minitab usage.</li><li>Able to develop Dashboard (PowerBI) and to apply Data Science (Python, R).</li></ul>

Responsibilities: Quality System &amp; Compliance <ul><li>Develop and implement quality and reliability processes to support NPI.</li><li>Lead the development and scaling of the site Quality Management System (QMS).</li><li>Ensure QMS elements (management reviews, internal audits, supplier management) comply with global standards.</li><li>Act as Lead Auditor for internal audits and ensure compliance with ISO 13485 and FDA QSR.</li><li>Support external audits, including preparation, mock audits, and corrective actions.</li><li>Review and approve ECOs, DCOs, training matrices, and other NPI documentation.</li><li>Maintain updated quality policies and procedures aligned with evolving standards.</li></ul> NPI Planning &amp; Execution <ul><li>Represent Quality in customer meetings and business reviews.</li><li>Collaborate with cross-functional teams including engineering, manufacturing, PMO, and supply chain.</li><li>Support implementation of electronic quality systems for improved traceability and documentation.</li><li>Evaluate product development objectives to identify quality improvement opportunities.</li><li>Create, review, and maintain quality system documents specific to NPI.</li><li>Calculate and present NPI quality KPIs.</li></ul> Continuous Improvement &amp; Problem Solving <ul><li>Lead or support quality system improvement projects.</li><li>Use statistical and scientific methods to analyze data and drive improvements.</li><li>Provide expertise in CAPA, root cause analysis, and reliability engineering tools.</li><li>Facilitate cross-functional improvement teams focused on NPI processes.</li></ul> Training &amp; Leadership <ul><li>Conduct training in GDP, GMP, CAPA, and compliance topics.</li><li>Oversee CAPA investigations to ensure true root cause identification and effective corrective actions.</li><li>Supervise and mentor Quality Engineers supporting NPI initiatives.</li></ul> Requirements: Required Skills &amp; Competencies Core Competencies <ul><li>Strong technical learning ability</li><li>Excellent problem-solving and analytical thinking</li><li>High ethical standards and integrity</li><li>Action-oriented and self-driven</li></ul> Job-Specific Skills <ul><li>Knowledge of NCMRs, CARs, CAPA, customer complaints, RMA metrics, DPPM, and DLPM</li><li>Strong technical "hands-on" skills</li><li>Excellent communication and interpersonal abilities</li><li>Ability to manage multiple tasks in a fast-paced environment</li><li>Strong prioritization and organizational skills</li><li>Proficiency in Microsoft Office (Word, Excel, PowerPoint, Visio)</li><li>Advanced technical report writing skills</li><li>Strong understanding of ISO 13485 and FDA QSR</li><li>Bilingual English (Advanced) / Spanish preferred</li><li>Willingness to travel up to 20% (based in Costa Rica)</li></ul> Experience &amp; Education <ul><li>Experience: 5+ years of Quality leadership experience in a manufacturing environment, preferably in multinational settings and NPI roles.</li><li>Education: Bachelor’s degree in a scientific or engineering discipline.</li><li>Certifications: CQE/CSSBB certification preferred.</li></ul>

Responsibilities: Sample Management <ul><li>Performs QC sample/reference standard/chromatographic column receipt, processing, distribution for testing and storage.</li><li>Performs QC sample reconciliation and disposal.</li><li>Tracks inventory of product samples, stability samples, and test materials in the lab.</li><li>Uses laboratory software for sample, reference standard, chromatographic column management.</li><li>Verifies accuracy of labeling/documentation provided with samples.</li><li>Informs QC Coordinator if chemical or reference standard is expired for removal from laboratory area.</li><li>Send samples for outside testing. Submit samples to the appropriate labs for testing.</li><li>Create and maintain reports including quality data trending, informational spreadsheets, laboratory log spreadsheets.</li><li>Compile a list of necessary laboratory supplies specifically reference standards, contacting vendors to obtain quotes.</li><li>Uses the purchasing system to procure laboratory supplies.</li><li>Provide status updates to QC management and other departments regarding the submission of samples.</li><li>Maintain a safe work environment by following standards and procedures and complying with legal regulations.</li></ul> Lab Equipment <ul><li>Maintains, operates equipment and instruments supporting sample processing.</li><li>Provides general laboratory support such as routine instrument cleaning/preventative maintenance/calibration, sample receiving, chemical inventory, document filing and housekeeping.</li><li>Works with internal resources to maintain lab in an optimal state. Cleans lab working surfaces and disposes of any excess chemicals, solutions, solvents, etc. in the special waste containers for each class of waste chemicals.</li><li>Under close supervision, learns to troubleshoot basic instrument problems.</li></ul> Investigations&nbsp; <ul><li>Escalates any trends/events to the QC Lab Manager.</li><li>Escalates any sample and reference standard documentation issues to the QC Lab Manager.</li><li>With guidance, participates in OOS/OOT/NOE and other investigations.</li><li>Assists, as and when needed, scientists working in the laboratory.</li><li>May assist in drafting, editing, and reviewing SOPs.</li></ul> Training <ul><li>Maintains assigned training records current and in-compliance.</li><li>May assist in the training of laboratory staff.</li></ul> Compliance&nbsp; <ul><li>Performs assigned work in a timely and safe manner conforming to regulatory, company and compendia requirements within pharmaceutical manufacturing setting.</li><li>Documents accurately data generated in notebooks/worksheets/LIMS in compliance with SOPs.</li><li>Follows internal processes related to controlled substances.</li></ul> Safety <ul><li>Follows EH&amp;S procedures to ensure a safe work environment.</li><li>Follows all applicable safety and standards guidelines, such as SOPs, cGMP, DEA regulations good documentation practice and/or MSDS.</li></ul> Requirements: Education &amp; Experience <ul><li>College graduate, preferably in a Science related field.</li><li>Laboratory experience related to sample management preferred.</li></ul> Knowledge <ul><li>Basic knowledge of sample management in a laboratory environment.</li><li>Some knowledge of applicable safety and standards guidelines: SOP, cGMP, GLP, DEA regulations and/or MSDS.</li><li>Competency in Microsoft Office Suite.</li><li>Proficiency with computer savvy.</li></ul> Skills &amp; Abilities <ul><li>Ability to display and analyze data in a logical manner.</li><li>Good verbal and written communication skills as well as good computer skills.</li><li>Attention to details and accurate record keeping.</li><li>Establish and maintain cooperative working relationships with others.</li><li>Solid organizational skills</li><li>Ability to take initiative, set priorities and follow through on assignments.</li></ul> Physical Requirements <ul><li>Extended periods of sitting, standing, walking, reaching, climbing/balancing, kneeling/crouching/crawling, looking at monitor for extended periods, moderate noise levels and potential business travel.</li><li>Work is in an FDA and DEA-regulated pharma lab environment with risk of exposure to various chemicals.</li><li>Must occasionally lift and/or move up to 15-25 lbs.</li><li>Ability to wear personal protective equipment, including respirators, gloves, etc.</li><li>Specific visions abilities are required by this job include close vision and color vision</li><li>Ability to occasionally tolerate significant differences in temperature and/or humidity for short periods.</li></ul>

Responsibilities: <ul><li>Provide real-time QA oversight on the production floor, in warehouse areas, and during qualification activities.</li><li>Perform batch record and logbook review, ensuring accuracy, completeness, and compliance with GDP standards.</li><li>Execute and document line clearance and room readiness inspections prior to manufacturing activities.</li><li>Review qualification and validation protocols for clarity, compliance, and alignment with regulatory and internal quality expectations.</li><li>Support execution of qualification protocols by providing on-site quality presence during testing and ensuring deviations are properly documented and escalated. 6.	Initiate, investigate, and support closure of deviations, non-conformances, and CAPAs related to manufacturing and qualification activities.</li><li>Collaborate with cross-functional teams to ensure timely and compliant execution of commissioning, qualification, and validation activities.</li><li>Support the development and maintenance of site-specific quality procedures (SOPs, work instructions, forms) governing manufacturing, warehousing, engineering, maintenance, and validation operations.</li><li>Review and approve site procedures to ensure clarity and compliance with cGMP standards.</li><li>Maintain awareness of site policies, cGMP regulations, and evolving regulatory expectations applicable to sterile injectable operations.</li><li>Participate in internal walkthroughs, audit preparations, and readiness activities for regulatory inspections.</li><li>Support the implementation of continuous improvement initiatives and site quality metrics.</li></ul> Requirements: Qualifications/Experience <ul><li>Bachelor’s degree in a scientific, engineering, or technical discipline (e.g., Biology, Chemistry, Pharmacy, Engineering)</li><li>2–5 years of experience in quality assurance, manufacturing, or validation in a cGMP-regulated pharmaceutical or biotech manufacturing environment</li><li>Working knowledge of FDA, EU, and ICH guidelines related to sterile manufacturing, validation, and data integrity</li><li>Experience supporting commissioning and qualification activities is strongly preferred</li><li>Familiarity with GDP, batch record review, and deviation documentation processes</li></ul> Skills/Competencies <ul><li>Strong attention to detail and commitment to compliance</li><li>Solid written and verbal communication skills</li><li>Ability to work collaboratively across departments in a fast-paced environment</li><li>Comfortable supporting shop-floor activities and cross-functional execution teams</li><li>Proficient in using quality systems and document management tools</li><li>Flexible and adaptable to changing priorities and evolving project timelines</li><li>Commitment to data integrity, continuous improvement, and patient safety</li></ul>

Responsibilities: <ul><li>Meeting with the product engineers to determine product testing parameters.</li><li>Conducting quality assurance and designing performance tests using the new testing procedures.</li><li>Troubleshooting any errors and streamlining the testing procedures. Ensuring all tests and procedures meet company and industry standards.</li><li>Preparing test reports for management.</li></ul> Requirements: <ul><li>BS Degree in Engineering or Science, 5+ years’ experience related to primary job function, Electrical Engineering preferred.</li><li>Experience with software such as Altium, Ultiboard, Multisim, AutoCAD, Space Claim, Creo, and LabVIEW desirable.</li><li>Experience with solid state power switching highly desirable.</li><li>Familiarity with 270Vdc and 1000Vdc applications desirable.</li><li>Effective communication and presentation skills required.</li><li>Ability to maintain focus and complete tasks independently and on time.</li><li>This position requires access to information which is subject to stringent controls under the International Traffic in Arms Regulations (ITAR) or Export Administration Regulations (EAR). Candidates must be a U.S. citizen or national, U.S. lawful permanent resident, person granted asylee status in the U.S., or person admitted into the U.S. as a refugee.</li></ul>

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62 test methods Jobs found

VAVE Staff Product Development Engineer

Senior Business Intelligence Analyst

Continuous Improvement Analyst III

Senior Manufacturing Engineer

Senior Manager Channel Sales

Quality Improvement Manager

Senior Quality & Reliability Engineer

QC Lab Sample Coordinator

QE Specialist

Senior Electrical Engineer

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Skills

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62 test methods Jobs found

VAVE Staff Product Development Engineer

Senior Business Intelligence Analyst

Continuous Improvement Analyst III

Senior Manufacturing Engineer

Senior Manager Channel Sales

Quality Improvement Manager

Senior Quality & Reliability Engineer

QC Lab Sample Coordinator

QE Specialist

Senior Electrical Engineer

WhiteCrow WhiteCrow is on a mission to connect companies with the best talent across the globe.

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WhiteCrow is on a mission to connect companies with the best talent across the globe.