Work Flexibility: Remote or Hybrid or Onsite

Senior Staff, Software Quality Assurance Engineer - Remote

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)

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, 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.

$115,600 - $245,800 salary plus bonus eligible + generally eligible for short-term and long-term financial incentives + benefits.  Individual pay is based on skills, experience, and other relevant factors.

Travel Percentage: 10%

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.

Stryker Corporation will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor’s legal duty to furnish information.