Job Description

Job Summary:

The Sr. Officer - Quality Assurance is responsible for ensuring compliance with ISO 13485:2016, ZED, GMP, and other regulatory standards related to the quality, packaging, labeling, storage, and distribution of surgical disposable products. The role involves managing quality systems, reviewing batch records, supporting audits and inspections, and ensuring robust documentation and training processes.

Key Responsibilities:

Ensure QMS compliance with ISO 13485:2016, ZED, and GMP standards. Review and approve batch records, SOPs, and quality documents. Oversee product packaging, labeling, testing, and release for dispatch. Investigate and manage deviations, complaints, CAPAs, and change controls. Monitor warehouse conditions, equipment calibrations, and validation records. Coordinate internal/external audits, inspections, and supplier evaluations. Ensure timely product testing and maintain ETO batch records. Conduct training sessions on quality procedures as per schedule. Prepare Certificates of Analysis and assist in regulatory certifications. Coordinate with cross-functional teams for QMS adherence and documentation.

Qualifications:

Bachelor's/Master's degree in Science, Pharmacy, or related field. Experience in Quality Assurance within a medical device or pharmaceutical environment preferred. Knowledge of ISO 13485, GMP, and regulatory compliance. Strong documentation, auditing, and communication skills.
Job Types: Full-time, Permanent

Pay: ?240,000.00 - ?400,000.00 per year

Schedule:

Fixed shift
Supplemental Pay:

Performance bonus Quarterly bonus
Work Location: In person