Quality Engineer
Stryker
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.
**What you will do:**
+ Investigates & document customer complaints according to applicable regulatory requirements and products.
+ Complete complaint investigation templates.
+ Performs collective analyses of product complaints and reports for trends and identification of potential corrective or preventive actions
+ Ensures timely investigation of and response to product complaints. This involves initiating and participating in investigations and corrective action arising from product complaints.
+ Work closely with stakeholders & team individuals and provides, direction & coaching to drive team engagement.
+ Manage stakeholder’s expectations and communicate with team for the successful completion of the project. Review project progress on periodic basis with stakeholders and ensure regular feedbacks, inputs for teams’ development and growth.
+ Collect inputs from all stakeholders & team members and use project management practices to monitor and control the progress of the project. Responsible for the timely and quality deliveries from the team.
+ Develop an open culture to instill confidence, diversity of perspectives and knowledge sharing.
**What you Need:**
+ Experience on Post Market Surveillance as per US FDA & EU MDR
+ Experience on Quality Management (ISO 13485 or 21 CFR 820)
+ Understanding on Medical Device Risk Management
+ Understanding of Medical Device Design Controls & Change Controls
+ Understanding of New Product Development (NPD) Cycle
+ Experience with TrackWise and Microsoft Project
+ Ability to influence, motivate and lead the cross functional team.
+ Ability to coach team members and develop them in role.
+ Project management experience and experience to lead & achieve global process improvement efforts.
+ Experience of working with multiple teams and collaborating across geographically spread multi-functional teams.
+ TrackWise complaint handling tool or equivalent
**Education**
+ BE/BTech/ME/MTech in Bio Medical / Mechanical Engineering / Electrical Engineering or related field from premier institutes
+ 4-7 years of experience in Medical Device domain
+ At least 2+ years of experience in complaint handling or customer quality.
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.
Stryker Corporation is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, or protected veteran status. Stryker is an EO employer – M/F/Veteran/Disability.
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