Engineer- Quality Assurance

Work Flexibility: Hybrid

Individual contributor role that requires expertise from a professional in field of medical device post market quality assurance/ customer quality. This individual follows methods and procedures for customer complaints to ensure that overall compliance is met. This individual collaborates with cross-functional teams on customer complaints & quality problems, ensures that effective corrective actions are implemented /

This role requires the use of judgement in applying professional expertise and is expected to work independently with minimal supervision. Role requires an understanding and application of regulations, procedures, and concepts of medical device post market surveillance. The job requires attention to detail in making evaluative judgements based on the analysis of information.

What you will do

• 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
• Collaborates effectively with cross functional and divisional partners to achieve goals.
• Effectively adapts style in global interactions accordingly.
• Develop understanding of Stryker products and processes 

What we need

• BE/BTech, ME/MTech in Mechanical Engineering / Electrical Engineering / Bio Medical 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 quality tools.

Tools -

• TrackWise complaint handling tool or equivalent
• Microsoft office Word & Excel