Senior Staff Quality Engineer

About the role

Stryker is hiring a Senior Staff Quality Engineer for our Endoscopy division in San Jose, CA.

Responsibilities

• Work closely with customers, sales/marketing/field personnel, and cross-functional teams to address top quality issues.
• Mentors, provides oversight and approval of NC/CAPA, and acts as a high-level expert in problem-solving and root-causing activities.
• Leads quality initiatives or projects.
• Recognized process owner, with expertise across multiple quality areas.
• Provides input into local, global, and corporate processes, represents function on review boards and teams.
• Reviews and approves change management activities, challenges effectiveness, and drives strong reviews.
• Interprets KPI trends, drives continuous improvement process.
• Advocates for Human Factor practices, proficient in the science of identification of mitigation.
• Engages in and may lead internal and external audits with regulatory representatives, providing effective narrative and description of topic of expertise and overview of the business.
• Manages audit logistics and/or preparation.
• Responsible for initiating, internal containment, and support of ship and product holds for potential product escapes.
• Coaches and mentors others in quality topics and activities.

Requirements

• Required Bachelor’s degree in a science, engineering or related discipline.
• Minimum 6 years of experience in Quality and/or Research & Development (R&D) within the medical device industry, supporting product development, design controls, risk management, quality systems, and post-market surveillance activities.
• Strong knowledge of medical device quality and regulatory requirements, including ISO 13485, Good Documentation Practices (GDP), Good Manufacturing Practices (GMP), post-market compliance requirements, and U.S. and international medical device regulations.
• Experience leading and supporting root cause investigations, nonconformance management, CAPA activities, complaint investigations, and post-market quality initiatives to drive continuous improvement and regulatory compliance.

Preferred

• Preferred Masters degree.
• Experience in interacting with regulatory agencies (FDA, MoH, TUV, etc.).
• Strong knowledge of Quality Concepts (e.g. Risk Management, CAPA, Audits, Statistics).
• ASQ Certified Quality Engineer (CQE) and/or Certified Reliability Engineer (CRE) certification preferred.
• Six Sigma Green Belt or Black Belt certification preferred, with demonstrated application of continuous improvement and process optimization methodologies.

Skills

• None specified in the job posting.

Benefits

• 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.

Pay

$133,400 - $222,300 USD Annual

Schedule

N/A