Continuous Improvement Analyst III

Senior Manufacturing Engineer

HR Business Partner IV

Compounding Technician

Filling Technician

Senior - Data Engineer

Continuous Improvement Analyst II

Senior Manager Channel Sales

Quality Improvement Manager

Senior Quality & Reliability Engineer

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>

Repsonibilites: <ul><li>Plant serves as a strategic business partner and trusted thought partner to Plant Leaders and in country senior Management.</li><li>This position is located on-site, but a hybrid work schedule will also be considered</li><li>Serve as the HR site leader for the Tullahoma facility, acting as a trusted advisor to site leadership and aligning HR support with key business initiatives.</li><li>Partner with the broader HR network to deliver strategic talent solutions, organizational design, and effectiveness initiatives, fostering a One HR mindset.</li><li>Provide guidance on leadership development, succession planning, and talent pipeline strategies to support long term organizational growth.</li><li>Champion diversity, engagement, and inclusion efforts, with a global mindset and focus on creating equitable access to development and information.</li><li>Coach and support managers on performance, team effectiveness, and employee development to enhance leadership capability and culture.</li><li>Lead and resolve complex employee relations matters, ensuring legal compliance and a respectful, inclusive workplace.</li><li>Design and implement talent development initiatives including stretch assignments, mentoring, and targeted training programs.</li><li>Lead HR project management efforts related to workforce transitions, organizational change, and process improvement initiatives.</li><li>Collaborate with cross-functional partners to deliver high-impact HR initiatives, ensuring clear communication, risk management, and timely execution.</li><li>Preferred: Experience supporting M&amp;A activities, including HR due diligence, integration planning, and workforce impact assessments.</li><li>Develop and manage detailed project plans for HR initiatives, including milestones, communications, and risk mitigation strategies</li></ul> Requirements: <ul><li>Bachelor’s or Master`s degree in business, Human Resource Management, Psychology, or any related field</li><li>10+ years of progressive, international, HR related experience; breadth of HR knowledge and skills in a variety of fields in international context, including Business Partner;</li><li>Experience in a manufacturing and or operations environment is strongly preferred.</li><li>Executive level and leadership experience; Experience influencing without authority Ability to influence, lead and drive execution into the functions/region through close partnership and collaboration with the broader HR function Proved track record in Organization Design, Change Leadership, Talent Management, and Organizational Development Ability to multi-task and work efficiently in a fast-paced, international matrix organization Strong project management and organizational skills.</li><li>Fluent English language skills Has advanced knowledge of regional labor laws and obligations and uses this knowledge to advise management, especially in conflict situations Excellent interpersonal, negotiation, and communication.</li><li>Ability to travel up to 10%</li></ul>

Responsibilities: <ul><li>Operate, monitor, and adjust sterile manufacturing equipment for formulation, filling, and packaging of IV bag products in compliance with SOPs, cGMP, and safety requirements.</li><li>Perform routine preventive maintenance and minor repairs on production equipment to maintain optimal operating conditions.</li><li>Serve as first-line troubleshooting support for equipment and process issues, escalating to engineering or maintenance as required.</li><li>Support equipment and process qualifications, including protocol review, execution participation, and documentation completion.</li><li>Assist in the creation, revision, and implementation of SOPs and production-related procedures.</li><li>Provide training, guidance, and on-the-job support to Production Technician I personnel.</li><li>Perform cleaning, changeover, and line clearance activities to maintain manufacturing operations.</li><li>Accurately complete batch records, logbooks, and production documentation in compliance with data integrity requirements and cGMP practices.</li><li>Review documentation completed by fellow members of the production team.</li><li>Collaborate with Quality Assurance during in-process checks, deviation investigations, and CAPA activities.</li><li>Adhere to DEA and site procedures for controlled substance handling, including documentation and security protocols.</li><li>Work closely with cross-functional teams including Engineering, Validation, and Quality to support operational readiness.</li><li>Operate isolator technology, including performing and verifying sanitization steps, and supporting advanced troubleshooting.</li><li>Ensure controlled substances are handled, documented, and stored per DEA and site requirements.</li><li>Participate in continuous improvement and lean manufacturing initiatives to enhance safety, quality, and efficiency.</li></ul> Requirements: Qualifications / Experience <ul><li>High school diploma or equivalent required; associate degree or technical certification in a mechanical, engineering, or life sciences discipline preferred.</li><li>Minimum of 5 years’ experience in pharmaceutical or regulated manufacturing in areas of compounding, filling, inspection, and secondary packaging. Experience with sterile products or IV bag production preferred.</li><li>Demonstrated mechanical aptitude with hands-on equipment troubleshooting and maintenance skills.</li><li>Knowledge of cGMP, aseptic processing, and controlled substance handling requirements.</li><li>Minimum of 3 years’ experience working with automated production equipment utilizing HMI or SCADA interface required.</li><li>Experience with isolator-based manufacturing strongly preferred.</li><li>Experience reading and following technical documents such as SOPs, maintenance procedures, electrical drawings, equipment arrangements, piping diagrams, and qualification protocols</li></ul> Skills / Competencies <ul><li>Demonstrated problem-solving and mechanical troubleshooting skills.</li><li>Ability to mentor and train less experienced technicians.</li><li>Excellent attention to detail and documentation accuracy.</li><li>Effective communication and teamwork skills.</li><li>Commitment to safety, quality, and data integrity.</li><li>At home working in cleanroom environments with PPE requirements.</li></ul>

Responsibilities: <ul><li>Operate, monitor, and adjust sterile manufacturing equipment for formulation, filling, and packaging of IV bag products in compliance with SOPs, cGMP, and safety requirements.</li><li>Perform routine preventive maintenance and minor repairs on production equipment to maintain optimal operating conditions.</li><li>Serve as first-line troubleshooting support for equipment and process issues, escalating to engineering or maintenance as required.</li><li>Support equipment and process qualifications, including protocol review, execution participation, and documentation completion.</li><li>Assist in the creation, revision, and implementation of SOPs and production-related procedures.</li><li>Provide training, guidance, and on-the-job support to Production Technician I personnel.</li><li>Perform cleaning, changeover, and line clearance activities to maintain manufacturing operations.</li><li>Accurately complete batch records, logbooks, and production documentation in compliance with data integrity requirements and cGMP practices.</li><li>Review documentation completed by fellow members of the production team.</li><li>Collaborate with Quality Assurance during in-process checks, deviation investigations, and CAPA activities.</li><li>Adhere to DEA and site procedures for controlled substance handling, including documentation and security protocols.</li><li>Work closely with cross-functional teams including Engineering, Validation, and Quality to support operational readiness.</li><li>Operate isolator technology, including performing and verifying sanitization steps, and supporting advanced troubleshooting.</li><li>Ensure controlled substances are handled, documented, and stored per DEA and site requirements.</li><li>Participate in continuous improvement and lean manufacturing initiatives to enhance safety, quality, and efficiency.</li></ul> Requirements: Qualifications / Experience&nbsp; <ul><li>High school diploma or equivalent required; associate degree or technical certification in a mechanical, engineering, or life sciences discipline preferred.</li><li>Minimum of 5 years’ experience in pharmaceutical or regulated manufacturing in areas of compounding, filling, inspection, and secondary packaging. Experience with sterile products or IV bag production preferred.</li><li>Demonstrated mechanical aptitude with hands-on equipment troubleshooting and maintenance skills.</li><li>Knowledge of cGMP, aseptic processing, and controlled substance handling requirements.</li><li>Minimum of 3 years’ experience working with automated production equipment utilizing HMI or SCADA interface required.</li><li>Experience with isolator-based manufacturing strongly preferred.</li><li>Experience reading and following technical documents such as SOPs, maintenance procedures, electrical drawings, equipment arrangements, piping diagrams, and qualification protocols</li></ul> Skills/Competencies <ul><li>Demonstrated problem-solving and mechanical troubleshooting skills.</li><li>Ability to mentor and train less experienced technicians.</li><li>Excellent attention to detail and documentation accuracy.</li><li>Effective communication and teamwork skills.</li><li>Commitment to safety, quality, and data integrity.</li><li>At home working in cleanroom environments with PPE requirements.</li></ul>

Responsibilities: <ul><li>Uses a set of tasks and techniques to work as a liaison among and elicit the needs of stakeholders to define and validate solutions that meet business needs, goals, or objectives.</li><li>Analyzes and synthesize information elicited from stakeholders, defines, and manages the plan to deliver requirements and documents, and manages requirements throughout the project life cycle.</li><li>Develop ETL (Extract, transform, load) process to help extract and manipulate data from multiple sources.</li><li>Reformulating or automating the existing data workflows to maximize their functioning and greater scalability.</li><li>Critically evaluate information gathered from multiple sources, reconcile conflicts, decompose high-level information into details, and produce actionable business insights out of it.</li><li>Need to conduct complex data analysis and improve data quality and efficiency.</li><li>Develop models to create reporting infrastructure/dashboards for business process management and data mining.</li><li>Design Summary, Detail, and Dashboard reports and management summaries which present data findings in a professional, concise, and readable format appropriate for content and audience.</li><li>Solve ad-hoc requirements of Management related to data for critical decision making</li><li>Troubleshoot data inaccuracies, identify root causes, and take corrective action</li><li>Effectively communicate and translate quantity findings (Storytelling with data) inclusive of key insights and actionable recommendations to optimize performance</li><li>Optimize reports to ensure a responsive solution when visualizing vast amounts of data.</li></ul> Requirements: <ul><li>5+ years of data engineering experience in ETL design, development, optimization &amp; testing using, Alteryx, Data Bricks, Cloud AWS Services, Python, SQL scripts,</li><li>5+ years of hands-on experience in business intelligence and in configuring, designing, and building visualizations and dashboards using Tableau and other BI tools (Tableau Prep, Tableau Dashboard, Tableau Server, Business Objects, Power BI, etc.)</li><li>Excellent problem-solving, communication, and organizational skills.&nbsp;</li><li>Experience in performance tuning and optimization of ETL processes to enhance efficiency and minimize data processing time</li><li>Detail-oriented with excellent time management and organizational skills to meet a critical deadline</li><li>Self-motivated, ability to prioritize work and multi-task across many assignments in a fast-paced work environment</li><li>Collaborated with cross-functional teams to gather requirements, design data models, and implement scalable data architectures to support business analytics and reporting needs</li><li>Proven ability to work independently and with a team.</li><li>Ability to interpret technical or dashboard structure</li><li>Experience in business domains – supply chain, pricing, sales &amp; marketing, sales, finances</li></ul>

Overview:﻿ <ul><li>Working with the Lean implementation team to integrate Lean tools into operations as well as drive performance improvement.&nbsp;</li><li>Act as the local subject matter expert for the Lean tools and be responsible for all Lean activities at the local site.&nbsp;</li><li>Develop and conduct the Lean star level plan by driving and monitoring the projects of operation advantage, providing necessary technical support and facilitating cross-functional team to meet the metrics as planned.&nbsp;</li></ul> Responsibilities: <ul><li>Overall manage plant annual lean plan, identifying key improvement priorities to enhance site performance in the eyes of all stakeholders.</li><li>To implement system in plant and achieve Star level plant through improvement activity.</li><li>Conduct site level workshops and VSM transformation projects with focus on achieving operational excellence.&nbsp;</li><li>Systematic to manager plant cost activity, identify/improve/control the efficiency, material, labor and be all aspect of the cost viewing. </li><li>Being responsible fofr driving conversion productivity.&nbsp;</li><li>Key member of global lean committee, share/provide/lead global projects and activities.</li><li>Take role as internal process/cost consultants, to assistant plant manager solve management issues</li><li>Provide leadership on lean thinking, lean processing and lean production, continue to promote the culture of continuous improvement.</li><li>Lead / lean know-how transfer projects, to implement, optimize and solve specific problems in operation&nbsp;</li></ul> Requirements: <ul><li>B.S. Degree in engineering or technical field.</li><li>Minimum 8 years working experiences, 3 years working experiences as Continuous Improvement at least.&nbsp;</li><li>Professional experience with focus on production, logistics or industrial engineering is an advantage.</li><li>Previous experience in leading both of continuous improvement activities and value stream transformation projects.</li><li>Good flexibility and can work under pressure</li><li>Demonstrate the ability to lead change, a great team-work player.</li><li>Excellent communication and coaching skills, strong leadership skills.</li><li>Ability to think strategically and execute tactically, being result-oriented.</li><li>Project management skills.</li><li>Fluent in both spoken and written English and local language is essential.</li><li class="ql-align-justify">Lean Six Sigma Black Belt Certification is an advantage</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>

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155 project execution Jobs found

Continuous Improvement Analyst III

Senior Manufacturing Engineer

HR Business Partner IV

Compounding Technician

Filling Technician

Senior - Data Engineer

Continuous Improvement Analyst II

Senior Manager Channel Sales

Quality Improvement Manager

Senior Quality & Reliability Engineer

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155 project execution Jobs found

Continuous Improvement Analyst III

Senior Manufacturing Engineer

HR Business Partner IV

Compounding Technician

Filling Technician

Senior - Data Engineer

Continuous Improvement Analyst II

Senior Manager Channel Sales

Quality Improvement Manager

Senior Quality & Reliability Engineer

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