Required Qualification
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 Valuable 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.
Positive 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.