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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.

Health benefits include: Medical and prescription drug insurance, dental insurance, vision insurance, critical illness insurance, accident insurance, hospital indemnity insurance, personalized healthcare support, wellbeing program and tobacco cessation program. Financial benefits include: Health Savings Account (HSA), Flexible Spending Accounts (FSAs), 401(k) plan, Employee Stock Purchase Plan (ESPP), basic life and AD&D insurance, and short-term disability insurance. Stryker offers innovative products and services in MedSurg, Neurotechnology, Orthopaedics and Spine that help improve patient and healthcare outcomes. Alongside its customers around the world, Stryker impacts more than 150 million patients annually. Depending on customer requirements employees and new hires in sales and field roles that require access to customer accounts as a function of the job may be required to obtain various vaccinations as an essential function of their role.

Stryker Corporation is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, or protected veteran status. Stryker is an EO employer – M/F/Veteran/Disability.