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Together with our customers, we're on a mission to make healthcare better.
The Role
The Quality Assurance Engineer will investigate and document customer complaints, ensure timely responses to product complaints, collaborate with cross-functional teams, and develop an understanding of Stryker products and processes.
Summary Generated by Built In
Work Flexibility: Hybrid
Post Market Surveillance - Customer Quality Engineer
- Investigates & document customer complaints according to applicable regulatory requirements and products.
- Ensures timely investigation of and response to product complaints. This involves initiating and participating in investigations and corrective action arising from product complaints.
- Proactive collaboration with cross functional team members to get resolution on customer complaints.
- Timely closure of customer complaints
- Communicate and Collaborates effectively with cross functional and divisional partners located gloabally to achieve goals.
- Effectively adapts style in global interactions accordingly.
- Develop understanding of Stryker products and processes
Experience and Skill Needed :-
- BE/BTech, ME/MTech in Bio Medical / Mechanical Engineering / Electrical Engineering or related field from premier institutes
- 2-6 years of experience in Medical Device domain preferred
- At least 2+ years of experience in complaint handling or customer quality.
- Understanding of Post Market Surveillance requirement of Medical Devices under FDA & EU MDR regulations
- Understanding on Medical Device Risk Management
- Hands-on Experience on Complaint handling and Product investigations of medical devices.
- Experience on root cause analysis of field returned products.
- Understanding on NC CAPA process.
- Knowledge of various quality tools.
Tools -
- TrackWise complaint handling tool or equivalent
- Salesforce
- Microsoft office Word & Excel
Travel Percentage: None
The Company
What We Do
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 www.stryker.com.
Together with our customers, we are driven to make healthcare better.
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