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Senior NPI Quality Engineer

3 months ago

Mahwah, United States Stryker Full time

Work Flexibility: Hybrid or Onsite

Senior NPI Quality Engineer - Hybrid or Onsite

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

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: Lead supplier qualification and ensure supplier processes meet Stryker's standards.
What you will need:

Required:
  • Bachelor of Science, Engineering or related subject
  • 4+ years' experience in a quality or technical discipline
  • Previous experience in a regulated environment within a manufacturing 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 language (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. 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.


Travel Percentage: 20%

Stryker Corporation is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, or protected veteran status. Stryker is an EO employer - M/F/Veteran/Disability.

Stryker Corporation will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor's legal duty to furnish information.