(REMOTE) Staff – Software Quality Engineer – Stryker

8% 1-Year Employee Growth Rate | 18% 2-Year Employee Growth Rate | LinkedIn | $0 Venture Funding

What Is Employee Growth Rate & Why Is It Important?

Why engineering at Stryker?

At Stryker we are dedicated to improving lives, with a passion for researching and developing new medical device products. As an engineer at Stryker, you will be proud of the work that you will be doing, using cutting-edge technologies to make healthcare better. Here, you will work in a supportive culture with other incredibly talented and intelligent people, creating industry-leading medical technology products. You will also have growth opportunities as we have a culture that supports your personal and professional development.

Need another reason to apply? Check out these 8 reasons to join Stryker’s engineering team: https://www.strykercareersblog.com/post/8-reasons-to-join-strykers-engineering-team

We are proud to be named one of the World’s Best Workplaces and a Best Workplace for Diversity by Fortune Magazine! Learn more about our award-winning organization by visiting stryker.com

Our benefits include bonuses; commissions; healthcare; insurance benefits; retirement programs; stock based plans; paid time off plans; family and parenting leaves; tuition reimbursement; wellness programs; onsite fitness centers and cafeterias; discount purchase programs; and service and performance awards – not to mention various social and recreational activities.

WHAT YOU WILL DO:

• Guide software development teams through our internal quality system(s) process to ensure products are developed in compliance with procedures and other regulations such as FDA part 820, part 11, HIPAA, ISO 13485, and SOC2.
• Actively participate in defining and updating quality system software processes to support quality software as required in alignment with regulations/compliance such as for change control, data privacy, software development, and security.
• Owns SOC2 compliance activities and participates in internal and external audits
• Perform risk analysis and develop mitigation strategies as appropriate.
• Present risks associated with the product/solution use during Design Reviews and track the design, and documentation to mitigate those issues throughout the development process.
• Influence new product development teams when defining design verification and validation test requirements to ensure design inputs and compliance requirements are met.
• Provides oversight for NC/CAPA activities
• Work with leadership and team members to solicit process requirements and drive organizational change for continuous process improvements.
• Function in an Agile (Scrum)/DevOps team while using ALM tools.
• Participate in daily scrums, sprint planning, and closing.

WHAT YOU WILL NEED:

Must Haves:

• Bachelor’s degree or equivalent in Engineering or Quality.
• 4+ years experience in a software engineering organization in a development or quality engineering role.
• Understanding of FDA, ISO, HIPAA, SOC2, and other regulations and standards.
• Strong knowledge of Quality Concepts (e.g. CAPA, Audits, Statistics).
• Experience in working in a compliance risk situation.
• Demonstrated ability to advocate for product excellence and quality.
• Demonstrated ability to effectively work cross-functionally with other departments, including Product Development, Operations, Regulatory Affairs, and Marketing.
• Working knowledge of process validation (GAMP5 – CSV – Computer Systems Validation)
• Working knowledge of different SDLCs (software development life cycle), particularly agile scrum/SAFe/DevOps model.
• Knowledge of cloud-based technologies such as Microsoft Azure (preferred) / Amazon Web Services.
• Applied knowledge of Good Documentation Practices (GDP)
• Experience implementing process improvements
• Must possess strong project management skills as well as have the ability to manage multiple tasks simultaneously.
• Demonstrated ability to successfully manage and complete projects in a matrix organization.

Nice to Haves:

• Experience with performing security assessments or audits.
• Experience working in a regulated environment preferably in software medical device R&D and manufacturing processes.
• Thorough knowledge and understanding of US and International Medical Device Regulations.
• Knowledge and understanding of AICPA SOC2 certification requirements

WHO WE WANT:

• Dedicated achievers. Relentless about quality, people thrive in a fast-paced environment and will stop at nothing to ensure a project is complete and meets regulations and expectations.
• Goal-oriented. Keeping the customer and system requirements squarely in focus, people who deliver safe and robust solutions.
• Analytical problem solvers. People who go beyond just fixing to identify root causes, evaluate optimal solutions, and recommend comprehensive upgrades to prevent future issues.
• Collaborative partners. People who build and leverage cross-functional relationships to bring together ideas, information, use cases, and industry analyses to develop best practices.

$81,300 – $173,300salary plus bonus eligible + Benefits (Health, Vision, Dental, 401K, Tuition Reimbursement, Employee Assistance Program, Wellbeing Program, Employee Stock Purchase Program). This information reflects the anticipated salary range for this position based on current national data. Actual minimum and maximum may vary based on location. Individual pay is based on skills, experience, and other relevant factors.

#DREEngineering

Know someone at Stryker?

Be sure to have them submit you as a referral prior to applying for this position. Learn more about our employee referral program at https://careers.stryker.com/referrals/

About Stryker

Stryker is one of the world’s leading medical technology companies and, together with our customers, is driven to make healthcare better. We offer innovative products and services in Orthopaedics, Medical and Surgical, and Neurotechnology and Spine that help improve patient and hospital outcomes.

We are proud to be named one of the World’s Best Workplaces and a Best Workplace for Diversity by Fortune Magazine! Learn more about our award-winning organization by visiting stryker.com

Tagged as: 501+ Employees, Hide US-Only Jobs, Venture Funded