Work Flexibility: Hybrid or Onsite

Quality Assurance Manager New Product Introduction

Mahwah, NJ

Stryker is seeking a Quality Assurance Manager – New Product Introduction (NPI) to lead and advocate for design-for-manufacture and assembly excellence. This role provides technical leadership in quality assurance for new product launches, ensuring robust process risk management and compliance with regulatory standards. The ideal candidate will drive cross-functional collaboration to deliver high-quality, scalable products at launch.

 Work Flexibility:
Hybrid: Candidates must reside within a commutable distance to Mahwah, NJ, and be able to work onsite several times per week.

What you will do:

Lead quality strategy for new product development, ensuring scalable, high-yield manufacturing processes.Drive robust process risk management, including pFMEA, CQAs, and process validation.Optimize inspection strategies through automation, lean principles, and supplier certification.Ensure implementation and oversight of production and process controls throughout manufacturing.Collaborate cross-functionally with design, operations, and global QA teams to ensure successful product launches.Monitor and improve product quality performance metrics, identifying opportunities for continuous improvement.Mentor and develop QA team members, supporting talent growth and performance excellence.Ensure compliance with FDA, ISO, and Stryker corporate quality standards during product introduction.

What you need:
Basic Qualifications:

Bachelor’s Degree in Engineering, Science discipline or related field.​8+ years of experience in a regulated manufacturing environment (Medical Device, Pharmaceutical, Biomedical, or Automotive).Experience leading and developing teams.

Preferred Qualifications:

In-depth knowledge of FDA regulations, ISO standards, and experience managing regulatory inspections/audits.Proficiency in quality tools such as SPC, FMEA, Root Cause Analysis, Poka-Yoke, and Six Sigma methodologies.

$120,600.00 - $198,700.00 salary plus bonus eligible + benefits. Actual minimum and maximum may vary based on location. Individual pay is based on skills, experience, and other relevant factors.

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.