Job Description

Responsible for

- Establishing, Maintaining and improving product quality
- Meeting Quality standards and regulatory requirements
- Compliance to Health, safety and environmental guidelines
- Conducting required checks and audits to ensure compliance to process standards
- Good understanding of part drawings
- Developing FMEA, Control plan for risk management
- Developing protocols (IQ, OQ, PQ) per risk management guidelines
- Incoming, inprocess and final inspection and batch acceptance
- Developing checking and test protocols
- Documentation of processes per SOP
- Vendor audits and Quality conformance of Vendors
- Customer and internal complaint resolution
- Handle Internal and external communications
- Measuring instruments and gages design, planning, use, calibration and maintenance
- 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

- Hands on with high precision components

General Requirements:

- Minimum 3 years' experience in precision automotive component industry or Medical device industry
- Preferably in Implantable 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 BSc. or Biomedical engineering with about 3-5 years of relevant industry experience

Job Type: Full-time

Pay: ₹360,000.00 - ₹420,000.00 per year

Benefits:

Health insurance Life insurance
Experience:

total work: 4 years (Required)
Work Location: In person