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 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.