Stryker is seeking a Senior Staff Software Quality Assurance Engineer to support its Digital Robotics and Enabling Technologies business by driving quality processes and ensuring compliance with internal procedures and regulatory standards.
Requirements
- 6+ years of experience in software quality or quality systems role, 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
- Knowledge of AICPA SOC 2 certification requirements or equivalent standards.
- Certifications such as Software Quality Engineer (CSQE) or equivalent.
Responsibilities
- 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
Other
- Bachelor’s degree in Software Engineering, Computer Science, or a related field.
- Experience with the medical device product development lifecycle.
