Quality Assurance, Post Market Specialist

Job description

Work Flexibility: Hybrid As the Quality Assurance Post Market Specialist , you will support activities that help ensure the safety, quality, and effectiveness of Stryker products. You will partner with cross-functional teams to evaluate product complaints, support regulatory reporting requirements, contribute to product field actions, and help maintain compliance with global post-market surveillance regulations. Your work will play an important role in supporting patient safety and product performance. What You Will Do 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. What You need 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 Office applications, including Word and Excel. Preferred 1 year of post-market surveillance, quality, regulatory affairs, clinical, or related experience within a regulated industry. Experience within the medical device industry. Prior exposure to medical device product development. Clinical or nursing experience. Critical care monitoring experience. ECG rhythm interpretation skills. Familiarity with complaint handling, adverse event reporting, CAPA, risk management, and field action activities. United States of America Pay Ranges: US15 : $83,400 - $139,000 USD Annual View the U.S. work location and transparency guide to find the pay range for your location. Travel Percentage: 10% Stryker Corporation is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, or protected veteran status. Stryker is an EO employer – M/F/Veteran/Disability. Stryker Corporation will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor’s legal duty to furnish information.