Post-Market Quality & Compliance Specialist

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

Job summary

Stryker is seeking a Quality Assurance Post Market Specialist to help ensure the safety, quality, and effectiveness of its products. You will partner with cross-functional teams to evaluate complaints, support regulatory reporting, contribute to field actions, and maintain compliance with global post-market surveillance regulations, ultimately supporting patient safety and product performance.

The role involves collaborating with Quality, Engineering, Clinical, and Marketing teams to aid

Qualifications

• Bachelor's degree.
• 0–2 years of post-market surveillance, quality, regulatory affairs, clinical, or related experience within a regulated industry.
• Strong verbal and written communication skills.
• Strong analytical, organizational, and problem-solving abilities.
• Ability to compose, review, and edit technical documentation.
• Experience collaborating with cross-functional teams.
• Proficiency with Microsoft Word and Microsoft Excel.

Responsibilities

• Support post-market surveillance activities to ensure compliance with U.S. and international regulatory requirements.
• Review product complaints and adverse event reports to assess reportability and determine whether device use contributed to patient harm.
• Interface with customers to collect patient information and additional details related to adverse event complaints.
• Collect, analyze, and report post-market adverse event data to regulatory agencies and cross-functional stakeholders.
• Support Product Field Action (PFA) and Medical Risk Assessment (MRA) activities.
• Provide quality and regulatory input for nonconformance investigations, CAPA activities, complaint investigations, and audit responses.
• Contribute to the development and maintenance of product hazard analyses and reportability guidance documents.
• Collaborate with Quality, Engineering, Clinical, and Marketing teams to support regulatory decision-making.
• Assist in preparing technical documentation and regulatory submissions.
• Maintain awareness of evolving global post-market surveillance regulations and industry requirements.

Skills

Communication

Analytical thinking

Documentation

Cross-functional collaboration

MS Office

Education

Bachelor's degree

Tools

Microsoft Word

Microsoft Excel

Job description

Stryker is seeking a Quality Assurance Post Market Specialist to help ensure the safety, quality, and effectiveness of its products. You will partner with cross-functional teams to evaluate complaints, support regulatory reporting, contribute to field actions, and maintain compliance with global post-market surveillance regulations, ultimately supporting patient safety and product performance.

The role involves collaborating with Quality, Engineering, Clinical, and Marketing teams to aid