Senior Staff, Software Quality Assurance Engineer
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:
- 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
Average salary estimate
If an employer mentions a salary or salary range on their job, we display it as an "Employer Estimate". If a job has no salary data, Rise displays an estimate if available.
Contribute to Stryker’s growth as an Upper Extremities Sales Associate by partnering with sales reps to educate medical professionals and manage product sales in Grand Rapids, MI.
Represent Stryker’s trauma products with expertise and commitment, impacting lives by supporting healthcare professionals in New Orleans.
Lead Design Quality Lifecycle Management at AbbVie to ensure compliant product launches and ongoing quality for medical devices and combination products.
Luxury Presence is seeking a hands-on Sr. QA Manager to drive quality engineering excellence and lead a high-performing QA team in a fast-growing remote environment.
Lead quality assurance operations at NexGen Contracting as a Quality Controls Manager, driving compliance and continuous improvement in project execution.
Alliance Laundry Systems is looking for a Quality Engineer in Ripon, WI to drive quality assurance and process control improvements in production.
Join RQM+ as a Quality System & Design Assurance Engineer Contractor to drive quality system compliance and risk management in a hybrid onsite role within the MedTech industry.
NVIDIA is hiring a Senior Software QA Test Development Engineer with strong Linux and AI tool experience to enhance their GPU and server platform testing efforts.
A remote Senior Quality Engineer position at Truelogic to lead automated testing for a healthcare platform leveraging conversational AI to improve patient care.
Contribute to Samsung's eCommerce platform development and quality assurance as an experienced Software Quality Engineer.
Lead the quality control efforts at San Gabriel Valley Medical Center as a QC-QA Coordinator ensuring accuracy and compliance in laboratory testing.
Lead Quality Risk Management initiatives at AbbVie to ensure regulatory compliance and integration of quality systems for diverse pharmaceutical and medical device products.
TWG Global seeks a skilled Senior AI QA Engineer to lead testing efforts for commercial AI products in a hybrid work setting.
A growing global team at City Electric Supply seeks a QA Analyst to improve logistics operations through testing and automation in a collaborative environment.
Seeking a Senior QA Engineer with strong manual and automated web application testing skills to join Truelogic’s remote team supporting a B2B digital marketing platform.
Together with our customers, we are driven to make healthcare better.
75 jobs
🔮
Hi, I'm Risa! Your AI Career Copilot
you, just ask me below!
