Senior Staff, Software Quality Assurance Engineer

Stryker

  • Michigan
  • Permanent
  • Full-time
  • 1 month ago
Work Flexibility: HybridSenior Staff, Software Quality Assurance EngineerStryker 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 regulatory standards, including FDA, HIPAA, ISO, and SOC 2.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:
  • Lead SOC 2 compliance activities and support internal and external audits.
  • Define and update quality system software processes to ensure compliance with regulations related to change control, data privacy, software development, and security.
  • Present product-related risks during design reviews and oversee mitigation throughout the product lifecycle.
  • Influence new product development by defining design verification and validation test requirements to ensure compliance with design inputs and regulatory standards.
  • Perform risk analyses and develop appropriate mitigation strategies.
  • Collaborate with leadership and cross-functional teams to gather process requirements and drive continuous improvement.
  • Conduct internal quality system audits and contribute to CAPA (Corrective and Preventive Action) initiatives.
  • Work within Agile (Scrum)/DevOps environments using ALM tools for defect tracking, traceability, and release/build management.
What you will need:Basic Qualifications:
  • Bachelor’s degree in Software Engineering, Computer Science, or a related field.
  • 6+ years of experience in software development or quality engineering roles.
  • Working knowledge of the Software Development Life Cycle (SDLC) and proficiency in Agile, Scrum, SAFe, and DevOps methodologies
  • Experience with cloud platforms, preferably Microsoft Azure or AWS
  • Knowledge of SOC 2, ISO, HIPAA, FDA, or other related regulatory standards
  • Proficient in Agile, Scrum, SAFe, and DevOps software development methodologies.
  • Solid understanding of quality systems, including CAPA, audits, and statistical analysis
Preferred Qualifications:
  • Knowledge of AICPA SOC 2 certification requirements or equivalent standards.
  • Familiarity with GAMP 5, Computer System Validation (CSV), and process validation
Travel Percentage: 20%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.

Stryker