Senior Quality Engineer- Design Assurance
We are looking for a driven and detail-oriented individual that has a passion for Quality in Product Sustenance. We need you to be an advocate for sustain quality into our designs. You will be joining a team of self-motivated, independent and creative thinkers, we work together and across function ensuring product excellence. Our team works within the Design Assurance function, but your role will have significant interaction with PD, Marketing, Regulatory and Operations.
As a Senior Quality Engineer, Design Assurance you will lead risk management processes and design control activities for product sustenance. Being a part of this team means that you are working cross functionally to drive our company’s mission and strengthen the Stryker brand. You should love solving novel problems in fast paced and stimulating environment.
What you will do:
• Working effectively with respective cross functional stakeholders in product sustenance and assessing health risk
• Own Risk assessment deliverables and review associated design controls
• Strong hold in verification and validation activities with a rigor to drive design philosophy
• Data analysis and use statistical analysis to drive and make inform decisions.
What you need-
- Minimum of 6+ years’ experience in risk management, testing and analysis ideally in a strongly regulated environment such as medical device, military or aerospace industry
- Preferably Bachelor’s Degree in Mechanical or Biomedical Engineering or equivalent
- Experience in risk management activities in product sustenance teams by developing risk management plans and reports, conducting risk reviews, verifying implementation and effectiveness of risk controls.
- Experience in the definition of design verification and validation test requirements that ensure appropriate objective evidence is available to support acceptance criteria.
- Participation in design reviews by identifying risks associated with the product use and tracking how the design, documentation, and manufacturing process mitigate those issues throughout the development process.
- Influential partnership with R&D to drive safety and performance during change
- Previous experience in data analysis and statistical techniques to drive appropriate risk management activities and prioritization of issues.
- Effective communication and previous experience in implementing compliance regulations and standards, including 21CFR820, ISO 13485, ISO 14971 throughout the design and development process.
- Working experience in medical device industry is preferred.
- Good knowledge with ISO 13485, ISO 14971, 21 CFR Part 820 standards
- Experience in working in highly engaged teams
