Manager, Quality Assurance - New Product Introduction (Hybrid)

Work Flexibility: Hybrid or Onsite

We are seeking a Manager, Quality Assurance - New Product Introduction for our Neurovascular division. This is a hybrid position based two to three days per week in our Salt Lake City, UT office.

As the Manager, Quality Assurance – NPI, you will serve as a global leader and strategic partner within the NPI Quality organization. This role champions design for manufacturability and assembly, providing technical leadership to ensure new products, processes, and technologies are introduced with robust process risk management and high‑quality outcomes. You will guide the team in driving preventative quality, strengthening process capability, and enabling successful, compliant product launches.

What You Will Do

• Lead the execution of NPI quality strategy to develop capable, scalable manufacturing processes and high‑yield product launches.

• Drive robust pFMEA, CQA identification, process validation, process capability, and supplier capability to ensure accurate risk identification and strong process controls.

• Oversee implementation of production and process controls, inspection strategies, and test method validations to support high-quality, low‑cost product introductions.

• Partner cross‑functionally with Design, Advanced Operations, GQO, and suppliers to strengthen collaboration, share best practices, and harmonize global NPI QA processes.

• Coach, develop, and empower NPI QA team members, ensuring strong technical capability, metrology expertise, and performance management practices.

• Build organizational capability through optimized, lean inspection approaches, automation opportunities, supplier certification, and technology‑enabled improvements.

• Monitor and influence quality performance indicators (supplier DPM, RFT, manufacturing loss, complaints, recalls) and identify opportunities for continuous improvement.

• Ensure adherence to corporate, GQO, and external regulatory requirements (including FDA and global standards), supporting high-quality design transfers and compliant product launches.

What You Need

Required

• Bachelor’s Degree in Engineering, Science discipline or equivalent

• Minimum of 8 years’ experience in medical device, pharmaceutical, biomedical, aerospace, automotive or other regulated manufacturing environments

• Minimum of 2 years’ experience and a proven track record of successfully building, managing, and developing a highly talented, engaged and performing team

• Expert working knowledge of regulatory requirements, standards, and regulations, with experience of managing inspections/audits by the FDA and other regulatory bodies

• Proven ability to build trust, navigate cross‑functional relationships, and advocate for quality in a technical environment

Preferred

• MBA or background in Business Management

• Proficiency in quality tools such as SPC, FMEA, RCA, Poka‑Yoke, and Six Sigma methodologies

• Experience across multiple quality roles, sites, or functions

• Expertise in metrology, GD&T, and interpretation of complex engineering drawings

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.