Senior Staff, Software Quality Assurance Engineer

Senior Staff, Software Quality Assurance Engineer Stryker is seeking a Senior Staff Software Quality Assurance Engineer to support our Digital Robotics and Enabling Technologies business by driving quality processes. In this role, you will partner with R&D software development teams to guide them through internal quality system processes and ensure compliance with regulatory standards, including FDA, HIPAA, ISO, and SOC 2. Work Flexibility: Hybrid: Candidates must reside within a commutable distance to Portage, MI, or Weston, FL and be available to work onsite several times per week. What you will do: • Lead SOC 2 compliance activities and support internal and external audits. • Define and update quality system software processes to ensure compliance with regulations related to change control, data privacy, software development, and security. • Present product-related risks during design reviews and oversee mitigation throughout the product lifecycle. • Influence new product development by defining design verification and validation test requirements to ensure compliance with design inputs and regulatory standards. • Perform risk analyses and develop appropriate mitigation strategies. • Collaborate with leadership and cross-functional teams to gather process requirements and drive continuous improvement. • Conduct internal quality system audits and contribute to CAPA (Corrective and Preventive Action) initiatives. • Work within Agile (Scrum)/DevOps environments using ALM tools for defect tracking, traceability, and release/build management. What you will need: Basic Qualifications: • Bachelor’s degree in Software Engineering, Computer Science, or a related field. • 6+ years of experience in software development or quality engineering roles. • Working knowledge of the Software Development Life Cycle (SDLC) and proficiency in Agile, Scrum, SAFe, and DevOps methodologies • Experience with cloud platforms, preferably Microsoft Azure or AWS • Knowledge of SOC 2, ISO, HIPAA, FDA, or other related regulatory standards • Proficient in Agile, Scrum, SAFe, and DevOps software development methodologies. • Solid understanding of quality systems, including CAPA, audits, and statistical analysis Preferred Qualifications: • Knowledge of AICPA SOC 2 certification requirements or equivalent standards. • Familiarity with GAMP 5, Computer System Validation (CSV), and process validation Apply tot his job Apply To this Job