Senior Quality Assurance Engineer

Join Stryker as a Senior Quality Assurance Engineer in Redmond WA supporting Emergency Care! In this role you will help ensure that life-saving medical devices meet the highest standards of quality and safety while driving initiatives that enhance product performance and compliance directly impacting patient outcomes worldwide. If youre passionate about quality and continuous improvement this is your opportunity to make a difference.

Work Flexibility:
Candidates must reside within a commutable distance to Redmond WA and be able to work onsite 4 days per week.

What you will do

• Ensure quality performance of products and manufacturing processes across operations and key business functions.

• Lead internal and supplier nonconformance investigations including problem definition containment root cause analysis and timely closure against agreed due dates.

• Manage and prioritize multiple quality initiatives simultaneously balancing competing priorities across cross-functional partners.

• Own corrective and preventive actions (CAPA) including documentation effectiveness checks and on-time completion through closure.

• Review and approve change control activities to support compliant implementation and sustained process performance.

• Analyze key performance indicator trends (e.g. defects scrap yield) and drive improvement actions to reduce waste and variation.

• Support process and equipment validation/qualification activities including protocol review execution support and report approval.

• Prepare audit evidence and support internal/external audits including response development and follow-up actions within committed timelines.

• Apply risk management and human factors considerations to manufacturing operations including risk assessments and mitigation planning.

What you will need

Required

• Bachelors degree in Science Engineering or a related discipline.

• Minimum 2 years of experience in quality manufacturing or engineering; experience in regulated industries is a plus but not required.

Preferred

• Knowledge of medical device manufacturing and quality system standards (e.g. ISO 13485 Good Manufacturing Practice).

• Lean Six Sigma training or certification.

• Experience with nonconformance management CAPA change control and audit support.

• Experience applying risk management tools and statistical methods (e.g. sampling plans process capability measurement system analysis Gauge R&R).

• Familiarity with regulatory bodies (e.g. FDA notified bodies Ministry of Health) and compliance expectations.

US15: $89400 - $148900 USD Annual

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