We are excited to be named one of the World's Best Workplaces by Fortune Magazine!
We are proud to offer you our total rewards package which includes bonuses, healthcare, insurance benefits, retirement programs, wellness programs, as well as service and performance awards not to mention various social and recreational activities, all of which are location specific.
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
Stryker is a global leader in medical technologies and, together with its customers, is driven to make healthcare better. The company offers innovative products and services in MedSurg, Neurotechnology, Orthopaedics and Spine that help improve patient and healthcare outcomes. Alongside its customers around the world, Stryker impacts more than 150 million patients annually.
