Stryker

Compensation

Full Description

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 internal procedures and regulatory standards (e.g SOC 2, ISO, FDA and HIPAA) 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: • Support software product teams by guiding them through internal quality processes and documentation requirements. • Participate in risk assessments, quality document reviews, design review and change control processes to ensure quality impacts are considered and addressed. • Ensure development activities align with applicable regulatory and compliance frameworks (e.g., SOC 2, ISO 27001, FDA 21 CFR Part 11, HIPAA, ISO 13485). • Lead SOC 2 compliance activities and support internal and external audits. • Support internal and external SOC2 audits • Ensure that cloud system validation and software lifecycle deliverables meet applicable standards and company policies. • Collaborate with leadership and cross-functional teams to identify process gaps and implement continuous improvements across the SDLC • Maintain and improve quality system documentation, including SOPs, work instructions and guidance documents. What you will need: Basic Qualifications: • Bachelor’s degree in Software Engineering, Computer Science, or a related field. • 6+ years of experience in software quality or quality systems role, ideally supporting cloud-based or SaaS products. • Strong understanding of software development lifecycles (SDLC) and how quality assurance fits into each stage • Experience with cloud platforms, preferably Microsoft Azure or AWS • Knowledge of SOC 2, ISO, HIPAA, FDA, or other related regulatory standards • Solid understanding of quality systems, audits, software change control and statistical analysis Preferred Qualifications: • Knowledge of AICPA SOC 2 certification requirements or equivalent standards. • Certifications such as Software Quality Engineer (CSQE) or equivalent. • Experience with the medical device product development lifecycle.