Quality Assurance Engineer

2 days ago

Bengaluru, Karnataka, India Intessence Solutions Pvt Ltd Full time ₹ 3,60,000 - ₹ 4,20,000 per year

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
  • 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, ₹420,000.00 per year

Benefits:

  • Health insurance
  • Life insurance

Experience:

  • total work: 4 years (Required)

Work Location: In person

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