Job Summary :
This role to ensure that all sterile medical devices manufactured at the plant meet the highest standards of quality, safety, and compliance. He / She must have strong understanding of regulatory requirements (such as ISO 13485, Indian Medical Device Rule-2017 etc) with respect to inspection & testing, and hands-on experience with quality control processes in a cleanroom or GMP-compliant environment.
Key Responsibilities:
- Supervise the team perform in-process and final inspection of sterile medical devices and components.
- Conduct sampling, testing, and documentation of raw & packaging materials, finished goods, sales return product, Stability study etc.
- Involve customer complaint investigation process and prepare necessary investigation reports.
- Ensure compliance with applicable regulatory standards (ISO 13485,IMDR, MDR etc.).
- Maintain and calibrate QC instruments and equipment.
- Prepare and review QC documentation, including SOP&aposs, inspection reports, COA, and deviation reports.
- Participate in internal audits and support external regulatory inspections.
- Identify and report non-conformities and assist in root cause analysis and CAPA implementation.
- Collaborate with production, R&D and QA teams to ensure product quality.
- Maintain cleanroom protocols and hygiene standards during inspections.
Qualifications & Skill
- Bachelors degree in Science, Engineering, Pharmacy, or a related field.
- 4-6 years of experience in quality control within the medical device industry.
- Familiarity with GMP, ISO 13485, and IMDR regulations.
- Proficient in using QC tools and instruments
- Strong documentation and analytical skills.
- Good communication and teamwork abilities.
- Experience with statistical quality control (SQC) and SPC tools.
