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Senior NPI Quality Engineer – Hybrid
Mahwah, NJ
Stryker is hiring a Senior NPI Quality Engineer in Mahwah, NJ! You will be responsible for process development, qualification, design transfer, launch, and post-launch monitoring of new products for the Joint Replacement Division. The role advocates and leads design for manufacture and assembly through technical leadership and provides direction in quality assurance, quality control and preventative activities. View our most recent launch: Triathlon Hinge !
Work Flexibility: Hybrid.
The candidate must reside within a commutable distance to Mahwah, NJ and is expected to be onsite at the facility multiple times/week.
Who we want:
- Collaborative partners. People who build and leverage cross-functional relationships to bring together ideas, information, use cases, and industry analyses to develop best practices.
- Analytical problem solvers. People who go beyond just fixing to identify root causes, evaluate optimal solutions, and recommend comprehensive upgrades to prevent future issues.
- Dedicated achievers. Relentless about quality, people who thrive in a fast-paced environment and will stop at nothing to ensure a project is complete and meets regulations and expectations.
What you will do:
- Drive Launch Excellence: Support the development, qualification, design transfer, and launch of new products.
- Voice of Quality: Be the voice of quality within the cross functional project team and advocate for preventative measures within new process design, a right-first-time approach & a future-fit outlook.
- Collaborative Partner: Foster strong relationships across design divisions, advanced operations, and GQO functions.
- Risk Management Strategy: Develop robust process risk management strategies and inspection plans using advanced tools like pFMEA. Utilize risk management tools and principles to identify and mitigate production risks, ensuring product safety and compliance.
- Inspection Leadership: Develop lean inspection strategies. Support selection of inspection methods.
- Validation Expertise: Develop and execute validation strategies to ensure reliable processes.
- Process Excellence: Apply statistical techniques to develop processes that are capable, scalable and produce high yield. Support NC’s & CAPA’s related to new products, and drive continuous improvement efforts.
- Supplier Quality: Support supplier qualification strategy and ensure supplier processes meet Stryker’s standards including approving supplier validations through Production Part Approval Process (PPAP).
What you will need:
Required:
- Bachelor of Science, Engineering or related subject
- 2+ years’ experience in a quality or technical discipline
- Previous experience in a regulated environment
Preferred:
- Experience in new product/process development, and/or knowledge of Design Controls phase gate process.
- Familiarity with ISO 13485, QSR, GDP, GMP
- Competency in Metrology including ability to interpret complex engineering drawings and understand geometrical dimensioning and tolerance rules (GD&T). Knowledge in selection & development of inspection techniques – automated inspection techniques such as CMM and vision systems a plus.
- Experience in designing, performing, analyzing validations – equipment, test method, process, computerized systems, spreadsheets. Familiarity with sterilization & packaging processes a plus.
- Experience in executing complex problem-solving and process improvements techniques related to design/process/technical issues using lean six sigma tools like DMAIC.
- Working knowledge/experience of risk based and statistical techniques, using tools such as FMEA.