Quality Assurance Specialist

Job Description

We are seeking a motivated and detail-oriented Quality Assurance Executive with 1–2 years of experience to join our team and support our commitment to delivering high-quality and compliant products. Responsibilities Assist in maintaining and improving the Quality Management System (QMS) in compliance with ISO 13485, 21 CFR Part 820, and applicable regulatory requirements. Perform routine document control activities including review, issuance, and archival of controlled documents. Support CAPA, Non-Conformance, and Change Control processes through documentation, investigation, and follow-up. Conduct in-process inspections, product release checks, and data recording as per established procedures. Participate in internal audits and supplier audits; prepare audit checklists and reports. Monitor and maintain calibration and preventive maintenance records for equipment. Coordinate with cross-functional teams for training compliance and documentation. Support batch manufacturing record review and ensure completeness and accuracy. Prepare reports related to quality metrics, deviations, and customer complaints. Ensure adherence to good documentation practices (GDP) across all records. Qualifications Bachelor’s degree in Pharmacy, Biotechnology, Biomedical Engineering, or related life sciences/engineering discipline. If you're committed to quality and looking to grow your career in a fast-paced, regulated industry, we invite you to apply on hr@projectkmt.com. Show more Show less