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01/02 Ganesh
Director at Core Edge Solutions LLP

Views:392 Applications:36 Rec. Actions:Recruiter Actions:4

Quality Engineer/Officer - Pharma/Healthcare Startup (4-6 yrs)

Bangalore Job Code: 26052

We are looking for Quality Engineer/Officer for Bangalore based start up urgently

Job description :

Job Title : Quality Engineer/Officer

Reporting To : Director - Operations

Main Responsibilities :

- Establishing, Maintaining and improving product quality

- Meeting regulatory requirements

- Compliance to Health, safety and environmental guidelines

- Meeting Quality standards

- Conducting required checks and audits to ensure compliance to process standards

- Developing checking protocols per risk management guidelines

- Documentation of processes per SOP

- Incoming inspection and batch acceptance

- Vendor audits and Quality conformance of Vendors

- Interact with customers and staff on a regular basis

- Handle Internal and external communications

- Periodic product and process audits

- Send parts for external testing per protocols

- Release parts/ batches per acceptance protocols

- Confirm process compliance per validated methods

- Batch hold/ production stop authorization in case of deviation to standards

- Preparing budgets related to initiatives to improve quality

- Provide goal and direction for staff to improve quality standards

General requirements :

- Minimum 2 years experience in Medical device industry

- Preferably in Implantable IVD or orthopedic devices

- Knowledge of clean room protocols and standards and exposure to working in sterile clean room environment

- Exposure to ISO 13485

- Knowledge and Exposure to MDR 2017 guidelines

- Very high commitment to Quality, high commitment to regulatory and HSE compliance

Candidate requirements-Self-starter :

- Team player

- Energetic and enthusiastic

- Continuous improvement mindset

- Quality focus and attention to detail

- Customer centric mindset

- Strong Leadership capabilities

- Good cross functional engagement skills

- Commitment and drive to be Best in class

- Good problem-solving abilities so as to improve services or products

Qualification :


- BE, or Diploma in Engineering, or B pharma or BSC microbiology or BSC chemistry with about 5 years of industry experience

Ganesh
Core Edge Solutions LLP

This job opening was posted long time back. It may not be active. Nor was it removed by the recruiter. Please use your discretion.

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