- B.Pharm / M.Pharm / B.Sc. / M.Sc. in Chemistry, Microbiology, Biotechnology, Life Sciences, or related discipline.
- Candidates with qualifications relevant to medical device quality management may also be considered.
Experience
- Fresher to 3 years of experience in Quality Control / Quality Assurance.
- Experience in medical devices, surgical sutures, pharmaceuticals, or sterile manufacturing will be preferred.
Required Skills
- Basic knowledge of ISO 13485 and medical device Quality Management Systems.
- Knowledge of Positive Manufacturing Practices and Good Documentation Practices.
- Understanding of QC testing, inspection, sampling, and product release procedures.
- Basic knowledge of CAPA, deviation handling, change control, risk management, and internal audits.
- Good documentation and record-maintenance skills.
- Proficiency in MS Word and Excel.
- Good communication and coordination skills.
- Attention to detail and ability to identify quality-related issues.
Preferred Knowledge
- ISO 13485:2016
- Medical Devices Rules, 2017
- Sterile medical device manufacturing
- EO sterilization
- Cleanroom practices and environmental monitoring
- Sterility and microbiological testing
- Equipment qualification and process validation
- Risk management as per ISO 14971
- Surgical suture testing and specifications
Key Performance Indicators
- Timely completion of QC testing and product release.
- Accuracy and completeness of quality documentation.
- Timely closure of CAPA, deviations, and non-conformances.
- Compliance with SOPs and regulatory requirements.
- Audit performance and closure of audit observations.
- Reduction in quality defects and documentation errors.