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

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