Quality Engineer-Post Market Surveillance
Location
Gurgaon | India
Job description
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 withotherincredibly talented and intelligentpeople, 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:
Who we want
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.
What you will do
Under direction, the Post Market Surveillance Analyst enters customer complaints into the company-wide complaint handling system and follows methods to analyze the complaints, for the Neurovascular business.
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.
What you need
Education/Special Training Required
P ost graduate in Biomed / Biotech
Qualifications/Work Experience Required
1-2 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.
About Stryker 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 130 million patients annually. More information is available at
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