Senior Quality Engineer-Post Market Surveillance

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

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• Data managers. People who enjoy compiling, organizing and consolidating large volumes of data and reports.
• Meticulous documenters. Detail-oriented people who enjoy maintaining meticulous documentation of reports, metrics, proposals, and presentations.
• Self-directed initiators. People who take ownership of their work and need no prompting to drive productivity, change, and outcomes.

• Reviews and determines reportability of complaints to FDA and international regulatory authorities.
• Writes, reviews, and files Medical Device Reports (MDRs) and international Vigilance Reports.
• Works closely with Sales Representatives and health care professionals to obtain additional information.
• Monitors quality, completeness and timeliness of complaint investigations.
• Writes customer response letters.
• Contributes to achieving team performance metrics and goals.
• Other duties as assigned.

• BA/BS degree in a technical or scientific discipline; and/or equivalent combination of education and experience.

• 3-5 years' of relevant work experience
• Strong written/verbal communication skills.
• Demonstrated ability to conduct a careful study of data and information in a methodical way
• Experience with FDA Medical Device Reporting, EU MDR & similar world wide regulations for complaint reporting is desired.