Hiring: Quality Assurance, Post Market Specialist Company: Stryker Location: Redmond, WA Job Posted Time: 2026-09-12 11:19:11 Target Skills & Keywords : Microsoft Excel, Microsoft Office, Quality Assurance, Risk Management About the job Experience: •0-2 years of post-market surveillance, quality, regulatory affairs, clinical, or related experience within a regulated industry. •2 years of post-market surveillance, quality, regulatory affairs, clinical, or related experience within a regulated industry. •1 year of post-market surveillance, quality, regulatory affairs, clinical, or related experience within a regulated industry. Required Skills: •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. •Partner cross-functionally with Quality, Engineering, Clinical, and Marketing teams to support regulatory decision-making. Qualifications: •Prior exposure to medical device product development. •Operational familiarity with complaint handling, adverse event reporting, CAPA, risk management, and field action activities. •View the U.S. work location and transparency guide to find the pay range for your location. Compensation: •$83,400 - $139,000 / year Interested candidates, please apply directly through the job posting on company's career page or try via AI auto apply on this platform. Don't miss this opportunity to join a forward-thinking team!