Senior Staff Software Advance Quality Engineer (REMOTE)

Stryker • Portage, MI

79d • $115,600 - $245,800 • Remote

About The Position

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).

Requirements

• Bachelor's degree in Software Engineering, Computer Science, or a related field.
• 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.

Nice To Haves

• 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.

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.
• Maintain and improve quality system documentation, including SOPs, work instructions and guidance documents.

Benefits

• Medical and prescription drug insurance
• Dental insurance
• Vision insurance
• Critical illness insurance
• Accident insurance
• Hospital indemnity insurance
• Personalized healthcare support
• Wellbeing program
• Tobacco cessation program
• Health Savings Account (HSA)
• Flexible Spending Accounts (FSAs)
• 401(k) plan
• Employee Stock Purchase Plan (ESPP)
• Basic life and AD&D insurance
• Short-term disability insurance

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Industry: Miscellaneous Manufacturing
• Education Level: Bachelor's degree