Post-Market Quality & Regulatory Specialist

Stryker; Redmond (WA); Hybrid; USD 83,000 - 139,000; Full time

Job summary

Stryker in Redmond, WA is seeking a Quality Assurance Post Market Specialist to support safety, quality, and effectiveness of Stryker products. You will partner with cross-functional teams to evaluate complaints, support regulatory reporting, and assist with field actions.

The role emphasizes collaboration with Quality, Engineering, Clinical, and Marketing, contributing to risk analyses, CAPA, and technical documentation while staying current with global post-market surveillance requirements.

Qualifications

• Bachelor's degree in a regulated industry preferred.
• Strong verbal and written communication skills.
• Experience collaborating with cross-functional teams.

Responsibilities

• Support post-market surveillance to ensure compliance with regulatory requirements.
• Review product complaints and adverse event reports for reportability.
• Interface with customers to gather patient information related to adverse events.
• Collect, analyze, and report post-market data to regulators and stakeholders.
• Support Product Field Action (PFA) and Medical Risk Assessment (MRA).
• Contribute to nonconformance investigations, CAPA, and audit responses.
• Assist in regulatory submissions and technical documentation.

Skills

Verbal communication

Written communication

Analytical skills

Problem solving

Cross-functional collaboration

Education

Bachelor's degree

Tools

Microsoft Office

Job description

Stryker in Redmond, WA is seeking a Quality Assurance Post Market Specialist to support safety, quality, and effectiveness of Stryker products. You will partner with cross-functional teams to evaluate complaints, support regulatory reporting, and assist with field actions.

The role emphasizes collaboration with Quality, Engineering, Clinical, and Marketing, contributing to risk analyses, CAPA, and technical documentation while staying current with global post-market surveillance requirements.