Quality Control Engineer

To ensure orthopedic medical devices (implants and instruments) conform to specified quality standards and are safe, sterile, and compliant with global regulatory requirements. The QC Executive is responsible for inspection, testing, and documentation of components and finished products at various stages of manufacturing.

Responsibilities:

1. Incoming Material & Component Inspection

• Inspect raw materials (stainless steel, titanium, PEEK, etc.) and orthopedic components (plates, screws, rods, etc.) for dimensional and material compliance.

• Verify CoAs, MTCs, and third-party test certificates.

2. In-Process & Final Product Inspection

• Conduct in-process quality checks during machining, polishing, passivation, laser marking, and packaging.

• Perform final inspection of implants and surgical instruments using precision measuring tools (vernier, micrometer, height gauge, CMM).

• Ensure compliance with drawings, tolerances, and finish quality.

3. Documentation & Regulatory Compliance

• Maintain test records, inspection reports, and batch release documents per ISO 13485 and FDA 21 CFR Part 820 requirements.

• Ensure traceability of components through DHR (Device History Records) and DMR (Device Master Records).

4. Testing & Validation Support

• Assist in mechanical testing (e.g., hardness, tensile, torque, fatigue).

• Support process and cleaning validation, and maintain reports.

5. Non-Conformance Management

• Identify and report non-conformances (NCRs).

• Assist in root cause analysis (RCA) and implementation of CAPA in coordination with QA.

6. Audit Readiness

• Maintain audit-ready documentation.

• Support internal audits and external inspections by regulatory bodies (CDSCO, Notified Body, US FDA, etc.).

Key Skills & Competencies:

• Proficient in reading and interpreting engineering drawings (GD&T knowledge is a plus).

• Attention to detail, good analytical and documentation skills.

🎓 Educational Qualification:

• Diploma / B.Tech in Mechanical/ B.E in Mechanical

• It is a Full Time मॅन्युफॅक्चरिंग job for candidates with 1 - 2 years of experience.

More about this Quality Control Engineer job

1. What is the eligibility criteria to apply for this Quality Control Engineer job?
   Ans: The candidate should be डिप्लोमा आणि त्याहून अधिक and above with 1 - 2 years of experience of experience
2. How much salary can I expect for this job role?
   Ans: You can expect a salary of ₹15000 - ₹17000 दरमहा that depends on your interview. It's a फुल टाईम job in Ahmedabad.
3. How many working days are there for this Quality Control Engineer job?
   Ans: This Quality Control Engineer job will have 6 working days.
4. Are there any charges applicable while applying or joining this Quality Control Engineer job?
   Ans: No, there is no fee applicable for applying this Quality Control Engineer job and during the employment with the company, i.e., BONETECH MEDISYS PRIVATE LIMITED.
5. Is it a work from home job?
   Ans: No, it’s not a work from home job and can't be done online.
6. How many openings are there for this Quality Control Engineer role?
   Ans: There is an immediate opening of 4 Quality Control Engineer at BONETECH MEDISYS PRIVATE LIMITED
7. Who can apply for this job?
   Ans: Only Male candidates can apply for this मॅन्युफॅक्चरिंग job.
8. What are the timings of this Quality Control Engineer job?
   Ans: This Quality Control Engineer job has Day Shift.