Production Technician I

Structural Engineer

VAVE Staff Product Development Engineer

Card Authorisation & Fraud Detection Analyst

Associate Data Engineer

Senior Manufacturing Engineer

HR Business Partner IV

Senior - Data Engineer

Senior Manager Channel Sales

Senior Quality & Reliability Engineer

Responsibilities: <ul><li>Operate, monitor, and adjust sterile manufacturing equipment used for formulation, filling, and packaging of IV bag products in compliance with cGMP and SOPs.</li><li>Perform routine preventive maintenance on production equipment to ensure operational readiness and minimize downtime.</li><li>Support equipment and process qualifications, including execution assistance, documentation support, and adherence to qualification protocols.</li><li>Act as first-line troubleshooting support for mechanical or operational equipment issues, escalating to Engineering or Maintenance as required.</li><li>Assist with isolator technology operations, including cleaning, sterilization, and environmental control procedures.</li><li>Participate in line clearance, changeover, and cleaning activities to maintain continuous production operations.</li><li>Accurately complete batch records, logbooks, and production documentation in compliance with data integrity and cGMP requirements.</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>Contribute to continuous improvement initiatives focused on safety, efficiency, and product quality.</li><li>Work closely with cross-functional teams, including Engineering, Validation, and Quality, to support operational readiness.</li><li>Comply with all Environmental Health &amp; Safety (EHS) standards and maintain a clean and safe work environment.</li></ul> Key Stakeholders Internal <ul><li>Production Supervisor and Production Manager</li><li>Engineering and Maintenance</li><li>Validation and Quality Assurance</li><li>Materials and Warehouse Teams</li><li>Environmental Health &amp; Safety (EHS)</li></ul> External <ul><li>Equipment vendors and service technicians (as required)</li></ul> Requirements: Qualifications &amp; Experience <ul><li>High school diploma or equivalent required; Associate degree or technical certification in mechanical, engineering, or life sciences preferred.</li><li>Minimum 2 years of experience in pharmaceutical or other regulated manufacturing environments, including compounding, filling, inspection, or secondary packaging.</li><li>Prior experience with sterile products or IV bag manufacturing strongly preferred.</li><li>Strong mechanical aptitude with the ability to perform routine maintenance and troubleshoot equipment issues.</li><li>Experience operating automated production equipment using HMI or SCADA interfaces required.</li><li>Working knowledge of cGMP, aseptic processing, and controlled substance regulations preferred.</li><li>Ability to read, understand, and follow SOPs, maintenance procedures, and qualification protocols.</li></ul> Skills &amp; Competencies <ul><li>Strong technical and mechanical problem-solving skills</li><li>High attention to detail with a commitment to quality and data integrity</li><li>Ability to work effectively in a fast-paced, highly regulated environment</li><li>Strong verbal and written communication skills</li><li>Team-oriented mindset with a collaborative approach</li><li>Comfortable working in cleanroom environments with PPE requirements</li></ul>

Role Description: <ul><li>This position will require an experienced, results-oriented professional to be responsible for Structural engineering.</li><li>The position will work in a multi-discipline team executing a variety of chemical manufacturing support projects and tasks to support our manufacturing sites.</li></ul> Responsibilities: <ul><li>Work with remote team members and global counterparts to develop deliverables required for structural fabrication and installation of projects and hence excellent communication skills a pre-requisite.</li><li>Provide structural analysis and engineering calculations of a variety of material types including but not limited to steel and concrete.</li><li>Provide structural analysis of steel and concrete elements.</li><li>Well versed with connection design calculations.</li><li>Participate in team model reviews.</li><li>Review Design Drawings</li></ul> Requirements: Basic Qualifications: <ul><li>Master’s degree in Structural Engineering from a reputed premiere institute.</li><li>Minimum 5 years of work experience in an Engineering and/or Engineering Services organization.</li><li>Must have engineering experience performing structural calculations and analysis of structures.</li><li>Computer Environment: Microsoft: Word, Excel, Power Point</li><li>Proficiency in STAAD Pro software</li><li>Should have exposure to environments of 2D and 3D CAD tools including Laser Scans, Bentley MicroStation, AVEVA and AutoCAD platforms or equivalent.</li><li>Experience with applicable industry codes including ACI, AISC, IBC and ability to utilize custom internal specifications as they apply to design and installation of structural assemblies and supports. Be able to perform tasks using U.S. or metric standards</li><li>Excellent written, listening, and verbal communication skills.</li></ul> Preferred Qualifications: <ul><li>Exposure to environments of 2D and 3D CAD tools including Laser Scans, Bentley MicroStation, AVEVA and AutoCAD platforms or equivalent.</li><li>Experience with applicable industry codes including ACI, AISC, IBC and ability to utilize custom internal specifications as they apply to design and installation of structural assemblies and supports. Be able to perform tasks using U.S. or metric standards.</li></ul>

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>

Responsibilities&nbsp;: Authoriser - Card Authorisation&nbsp;<ul><li>Process and authorize credit &amp; debit card transactions in a timely and accurate manner.&nbsp;</li><li>Perform voice-authorisation and give assistance to merchants and customers at POS transactions.&nbsp;</li><li>Meeting Service Level Agreements (SLA) standards on pick-up call (for merchants and customers).&nbsp;</li><li>Manage email duties, assisting Call Centre &amp; RMs on block/unblock cards, temporary increase limit adjustment, and bypass security check for customers.&nbsp;</li><li>Support Cards &amp; Payments (CPP) Cards Operations to process Authorisation code for unsecured products.&nbsp;</li></ul> Authoriser – Merchant and Customer Support <ul><li>Establish and maintain relationships with merchants, providing support and guidance on credit &amp; debit card transaction processes.&nbsp;</li><li>Assist merchants with inquiries and resolve any issues related to card authorizations.&nbsp;</li><li>Assist in transaction code cancellation request receive from merchants, customers and Contact Centre.&nbsp;</li><li>Respond to customer inquiries regarding credit &amp; debit card transactions and account statuses.&nbsp;</li><li>Educate customers on card usage, security, and fraud prevention.&nbsp;</li><li>Assist customer to adjust Temp Increase Limit.&nbsp;</li><li>24/7 emergency card replacement support.&nbsp;&nbsp;</li><li>Act as point-of-contact with Card Scheme&nbsp;&nbsp;</li></ul> Authoriser – Card Surveillance Support (transaction monitoring)&nbsp; <ul><li>Monitor and review card transactions for potential fraud and irregularities.&nbsp;</li><li>Monitor cards transaction in real time alerts queue and identify high risk transactions.&nbsp;&nbsp;</li><li>Monitor and analyze transactions to detect fraudulent activities using Visa/Mastercard fraud detection tools.&nbsp;</li><li>Observe customer transactions and identify suspicious and fraudulent activities such as account take over (scam fraud), friendly fraud, lost &amp; stolen card, and Credit Master attacks. Block/unblock cards, and attempt transaction cancellation when necessary.&nbsp;&nbsp;</li><li>Contact customer or manually trigger SMS notification to alert customer of suspicious transaction and perform verification with customer.&nbsp;</li><li>Follow-up on uncontactable customer by calling or sending SMS to notify to mitigate losses.&nbsp;</li><li>Manage customers expectation and explain to customer on fraudulent transactions and scam activities.&nbsp;</li><li>Support Fraud Investigation Team and Fraud Issuing team when required on fraud matters.&nbsp;</li><li>Perform merchant ID blocking to prevent Bin attack fraud and support CPP on parameter maintenance for 3DS system.&nbsp;</li></ul> Requirements: <ul><li>Diploma or equivalent qualification preferred.&nbsp;</li><li>Proficient in English. Ability to converse in in Mandarin (and dialects), Bahasa Malay, Tamil will be a plus.&nbsp;&nbsp;</li><li>Able to use MS Office and possess good written and communication skills.&nbsp;</li><li>Pleasant disposition with good interpersonal skills.&nbsp;</li><li>Possess strong analytical skills.&nbsp;</li><li>Possess high standard of customer service.&nbsp;</li><li>Manage task and responsibilities with minimal supervision. Take initiative and be proactive in solving problems.&nbsp;</li><li>Be a Team player, collaborate effectively with colleagues, and assist team members when needed, fostering a&nbsp;positive team.&nbsp;&nbsp;</li><li>Ability to work both independently and collaboratively in a fast-paced environment.&nbsp;</li><li>Able to perform 24 hours rotating shift including weekend &amp; public holiday and to be on standby for recall when&nbsp;called upon.&nbsp;&nbsp;</li><li>Ability to work in a fast-paced environment with ability to take pressure and meet the demands of the job.&nbsp;</li><li>Previous experience on fraud surveillance in banking sector or law enforcement agencies will highly be&nbsp;considered.&nbsp;</li><li>Keen interest in scam prevention&nbsp;</li></ul>

Responsibilities: <ul><li>Ability to troubleshoot problems in a live environment and provide real time help with critical issues.</li><li>Write code that is easily understood and maintainable by other team members.</li><li>Keep up to date with developments in technologies we are using.</li><li>Ability to communicate and work effectively, supporting various business departments.</li><li>Ability to work in fast-paced interdisciplinary environment.</li></ul> Requirements <ul><li>BA/BS in Computer Science or equivalent practical experience.&nbsp;</li><li>At least 3+ years of post-university experience as a full-stack engineer.</li><li>Solid knowledge of programming fundamentals—algorithms, data structures, design patterns, and paradigms.</li><li>Strong knowledge of Python.</li><li>Solid knowledge SQL and relational databases.</li><li>Knowledge of Extract-Transform-Load (ETL) and big data analytics tools.</li><li>Experience working in a cloud environment (AWS, Azure, GCP).</li><li>Familiarity with popular Python data analytics frameworks.</li><li>Familiarity with Snowflake or other large analytics engines.</li><li>Experience with data warehousing and working in environments with large scale, complex analytics requirements.</li><li>Familiarity with DAG-based job scheduling tools.</li><li>Cloud-native container orchestration platforms and tools.</li><li>Experience working in the Financial Services industry.</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>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>

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>

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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152 agile environment Jobs found

Production Technician I

Structural Engineer

VAVE Staff Product Development Engineer

Card Authorisation & Fraud Detection Analyst

Associate Data Engineer

Senior Manufacturing Engineer

HR Business Partner IV

Senior - Data Engineer

Senior Manager Channel Sales

Senior Quality & Reliability Engineer

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Skills

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152 agile environment Jobs found

Production Technician I

Structural Engineer

VAVE Staff Product Development Engineer

Card Authorisation & Fraud Detection Analyst

Associate Data Engineer

Senior Manufacturing Engineer

HR Business Partner IV

Senior - Data Engineer

Senior Manager Channel Sales

Senior Quality & Reliability Engineer

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