Biorad medisys
15+Years
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Position: Manager – Quality Control
Company: Biorad Medisys Pvt Ltd
Department: Quality Control
Location: Vemgal, Kolar, Karnataka
Employment Type: Full-Time
Manager – Quality Control | Biorad Medisys Pvt Ltd | Karnataka
FYND Talent Solutions is sharing an exciting career opportunity for experienced Quality Control professionals in the Medical Device industry.
Eligibility
* BE or MSc in Engineering or Life Sciences
* 15+ years of Quality Control experience
* Experience in the Medical Device industry is preferred
* Knowledge of ISO 13485, MDR, and FDA regulations
* CQE and Lead Auditor Certification will be an added advantage
Key Responsibilities
* Lead Quality Control laboratory operations and ensure compliance with applicable quality standards.
* Ensure adherence to ISO 13485, MDR, FDA, and regulatory requirements.
* Manage testing, calibration, incoming inspection, in-process inspections, and final product testing.
* Develop, implement, and maintain QC SOPs, protocols, and documentation.
* Investigate deviations, OOS, and OOT results and drive effective CAPA implementation.
* Oversee equipment calibration, method validation, and stability studies.
* Mentor, lead, and develop the Quality Control team while promoting continuous improvement initiatives.
Required Skills
* Strong understanding of Quality Management Systems (QMS)
* Knowledge of ISO 13485, MDR, and FDA regulations
* Expertise in laboratory operations and quality documentation
* Analytical problem-solving and decision-making abilities
* Leadership, communication, and team management skills
* Experience with CAPA, investigations, audits, and compliance activities
Disclaimer:
FYND Talent Solutions is an independent recruitment platform. This job is shared for informational purposes only and is not an official communication from the hiring company unless explicitly stated.
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