Senior Staff, Software Quality Assurance Engineer
Senior Staff, Software Quality Assurance Engineer
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Job Description
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 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:
- Bachelors 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
Required Experience:
Senior IC
Employment Type
Full-Time
