Position: Assistant Manager – Quality Assurance (QA)
Department: Quality Assurance
Reporting To: AGM – Quality Assurance
Experience: 6–7 Years
Category: Staff
We are looking for an experienced Assistant Manager – Quality Assurance to support and strengthen the organization's Quality Management System (QMS) while ensuring compliance with ISO 13485, EU Medical Device Regulation (MDR 2017/745), and 21 CFR Part 820. The ideal candidate should possess strong knowledge of medical device quality systems, regulatory compliance, internal audits, CAPA, and quality documentation.
- Support, review, and continuously improve Quality Management System (QMS) processes.
- Prepare, update, and maintain Quality System procedures, SOPs, and work instructions.
- Monitor and maintain existing quality processes to ensure compliance.
- Assist in planning and conducting internal and external quality audits.
- Maintain internal audit schedules, records, and CAPA tracking.
- Support Notified Body and regulatory audits, including preparation and follow-up actions.
- Investigate quality issues, non-conformities, and customer complaints to identify root causes.
- Collaborate with cross-functional teams to implement effective corrective and preventive actions.
- Ensure quality system requirements are understood and implemented across the organization.
- Manage QMS documentation, change control records, and quality records.
- Maintain Device Master Records (DMR), Technical Files, product conformity documentation, and test reports.
- Support international product registrations and regulatory documentation as required.
- Ensure compliance with applicable medical device regulations and quality standards.
- Bachelor's degree in Life Sciences, Engineering, Pharmacy, Biotechnology, or a related field (Master's degree preferred).
- 6–7 years of Quality Assurance experience in the Medical Device Industry.
- Hands-on experience with ISO 13485, EU MDR 2017/745, and 21 CFR Part 820.
- Experience in internal/external audits, CAPA, complaint handling, and regulatory documentation.
- Strong understanding of Quality Management Systems (QMS).
- Knowledge of medical device regulations and regulatory compliance.
- Excellent documentation and record management skills.
- Strong analytical and problem-solving abilities.
- High attention to detail and accuracy.
- Good communication and interpersonal skills.
- Proficiency in Microsoft Office (Excel, Word, PowerPoint).
- Ability to work independently as well as in cross-functional teams.
- Ability to perform effectively in a fast-paced environment.
- Experience handling regulatory inspections and Notified Body audits.
- Knowledge of risk management and product lifecycle documentation.
- Familiarity with international product registration processes.
