QC Manager

7 days ago

Bengaluru, India Winglobe Healthcare Pvt Ltd Full time

Job Title: Quality Control (QC) Manager

Department: Quality Control / Quality Assurance

Location: Nayandahalli, Bangalore

Job Description:

The QC Executive will be responsible for inspecting and ensuring the quality of CNC Sliding Head production components, precision medical devices such as spine implants, and cardiology-related products. The role includes visual and dimensional inspection, documentation preparation, and compliance with regulatory and customer specifications.

Key Responsibilities:

Inspection & Quality Checks:

Perform in-process and final inspection of CNC Sliding Head Machined Components.

Inspect spine implants and cardiology products (e.g., stents, delivery systems, etc.) as per drawings/specifications.

Use precision measuring instruments such as micrometers, vernier calipers, height gauges, profile projectors, and CMM (if applicable).

Conduct visual inspection under magnification (where required) for surface finish and critical features.

Documentation & Reporting:

Prepare Inspection Reports, Final QC Reports, and In-Process QC Check Sheets.

Maintain and manage DHR (Device History Record) and DHR review documentation for medical devices.

Assist in preparing COC (Certificate of Conformance), Test Certificates, and QA documentation for dispatch.

Ensure traceability and compliance with ISO 13485, GMP, and FDA standards where applicable.

Compliance & SOPs:

Follow standard operating procedures (SOPs) and work instructions.

Report non-conformances and initiate corrective actions in coordination with QA/Production teams.

Assist in internal and external audits related to quality systems and documentation.

Process Improvement:

Provide feedback for continual improvement of machining and inspection processes.

Collaborate with the production and engineering teams to reduce defects and improve yield.

Required Qualifications:

Education:

Diploma / B.E. / B.Tech in Mechanical Engineering, Biomedical Engineering, or equivalent.

Experience:

2–5 years of hands-on experience in QC inspection of precision machined components (preferably CNC Sliding Head).

Experience in medical device quality inspection – specifically orthopedic (spine implants) and cardiology products – is highly preferred.

Skills:

Proficient in interpreting engineering drawings and GD&T.

Familiar with ISO 13485 / GMP standards for medical devices.

Strong documentation and reporting skills.

Ability to use inspection tools and instruments with precision.

Basic knowledge of MS Office (Word, Excel) for report preparation.

Preferred:

Experience with cleanroom procedures and sterile packaging checks.

Exposure to regulatory audits (e.g., FDA, ISO).

Working knowledge of ERP systems for quality record management.

Interested can share your cv to 86210

Job Types: Full-time, Permanent

Pay: ₹40, ₹60,000.00 per month

Benefits:

  • Cell phone reimbursement
  • Flexible schedule
  • Food provided
  • Health insurance
  • Leave encashment
  • Life insurance
  • Paid sick time
  • Provident Fund

Work Location: In person

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