Quality Assurance Manager New Product Introduction - Stryker : Job Details

Quality Assurance Manager New Product Introduction

Join to apply for the Quality Assurance Manager New Product Introduction role at Stryker

Quality Assurance Manager New Product Introduction

Join to apply for the Quality Assurance Manager New Product Introduction role at Stryker

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Mahwah, NJStryker is seeking a

Mahwah, NJStryker 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.Health benefits include: Medical and prescription drug insurance, dental insurance, vision insurance, critical illness insurance, accident insurance, hospital indemnity insurance, personalized healthcare support, wellbeing program and tobacco cessation program. Financial benefits include: Health Savings Account (HSA), Flexible Spending Accounts (FSAs), 401(k) plan, Employee Stock Purchase Plan (ESPP), basic life and AD&D insurance, and short-term disability insurance. Stryker offers innovative products and services in MedSurg, Neurotechnology, Orthopaedics and Spine that help improve patient and healthcare outcomes. Alongside its customers around the world, Stryker impacts more than 150 million patients annually. Depending on customer requirements employees and new hires in sales and field roles that require access to customer accounts as a function of the job may be required to obtain various vaccinations as an essential function of their role.

Seniority level

• Seniority levelMid-Senior level

Employment type

• Employment typeFull-time

Job function

• Job functionQuality Assurance
• IndustriesAppliances, Electrical, and Electronics Manufacturing, Industrial Machinery Manufacturing, and Medical Equipment Manufacturing

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