Senior Staff Quality Engineer

Stryker; San Jose (CA); On-site; USD 133,000 - 222,000; Full time

Benefits offered by this job

Health insurance

Dental insurance

Vision insurance

Critical illness insurance

Accident insurance

Hospital indemnity insurance

Wellbeing program

Tobacco cessation program

HSA

FSAs

401(k)

ESP P

Life and AD&D insurance

Short-term disability

Job summary

Stryker is hiring a Senior Staff Quality Engineer for the Endoscopy division in San Jose, CA to provide quality engineering leadership and technical guidance in quality assurance, control, and preventative activities with a focus on continuous improvement.

You will mentor teams, lead quality initiatives, manage audits and CAPA, and ensure compliance with medical device regulations. This role requires collaboration across functions and a passion for data-driven quality improvements.

Qualifications

• Minimum 6 years of experience in Quality and/or R&D in the medical device industry.
• Strong knowledge of ISO 13485, GDP, GMP, post-market requirements, and global regulations.
• Experience leading root cause investigations, CAPA, complaint investigations, and post-market quality initiatives.

Responsibilities

• Collaborate with customers, sales, field personnel and cross-functional teams to address top quality issues.
• Mentor and provide oversight of NC/CAPA and high-level problem solving.
• Lead quality initiatives or projects and act as process owner across multiple quality areas.
• Provide input into local and global processes and participate in review boards and teams.
• Review and approve change management activities and drive effectiveness of reviews.
• Interpret KPI trends and drive continuous improvement.
• Engage in audits with regulatory reps and manage audit logistics if needed.
• Support ship/holds and potential product escapes; coach others in quality topics.

Skills

Quality leadership

Root cause analysis

CAPA management

Regulatory compliance

Education

Bachelor’s degree in science/engineering

Master’s degree (preferred)

Job description

Stryker is hiring a Senior Staff Quality Engineer for our Endoscopy division in San Jose, CA to provide quality engineering leadership and technical guidance in quality assurance, control, and preventative activities with a focus on continuous improvement of products and processes. Advocate and lead the execution of initiatives and projects to enhance quality performance within the business and for our customers. Mentor and provide technical direction across multiple areas of expertise. Ensure compliance with regulation and standards.

What You Will Do

• 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, activist and 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.
• Review and approval of change management activities, challenges effectiveness and drives strong review.
• Interpret KPI trends, drive continuous improvement process.
• Advocate of Human Factor practices, proficiency in the science of identification of mitigation.
• Engage 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. May manage audit logistics and/or preparation.
• Responsible for initiation, internal containment, and support of ship and product holds for potential product escapes.
• Coach and mentor others in quality topics and activities.

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

• 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.

$133,400 - $222,300 USD Annual

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.