Key Responsibilities
- Develop, review, update, and control all quality and regulatory documents for medical devices, including SOPs, work instructions, forms, templates, manuals, quality records, and controlled documents.
- Establish and maintain the risk management documentation system, including risk management files, hazard analysis, risk evaluation, risk control records, and residual risk documentation.
- Manage QMS documentation related to deviations, non-conformances, CAPA, change controls, complaints, training records, internal audits, management review, and supplier qualification.
- Prepare and control inward inspection records, incoming material inspection formats, acceptance records, and vendor quality documentation.
- Create and maintain batch manufacturing records, batch release documentation, device history records, inspection reports, traceability records, and related production documentation.
- Support regulatory documentation for product registrations, renewals, submissions, technical files, labeling documentation, declarations, and compliance dossiers.
- Maintain design and development documentation, including design history files, specifications, protocols, verification and validation records, reports, and engineering change documentation.
- Coordinate with QA, RA, R&D, production, stores, purchase, and operations teams to ensure completeness and compliance of records.
- Maintain documentation in an audit-ready state and support customer, certification, and regulatory audits.
Required Candidate Profile
- Bachelor's degree in Engineering, Biomedical Engineering, Pharmacy, Life Sciences, or a related discipline.
- 3–8 years of relevant experience in QARA documentation, compliance, and quality systems within the medical device industry.
- Hands-on experience in medical device documentation only; candidates from other industries should not be considered.
- Strong knowledge of QMS documentation, risk management documentation, regulatory documentation, and manufacturing record control.
- Proven experience in preparing and maintaining inward inspection records, batch records, device history records, CAPA, NCR, deviation, and change control documentation.
- Sound understanding of audit documentation, training records, supplier quality documentation, and document control systems.
- Good working knowledge of applicable medical device standards and regulatory expectations.
Preferred Skills
- Experience in setting up documentation systems and compliance structures from scratch.
- Familiarity with ISO 13485, medical device risk management practices, and design control documentation.
- Strong attention to detail, document accuracy, traceability, and audit preparedness.
- Good communication, follow-up, and cross-functional coordination skills.
- Proficiency in MS Office and documentation management practices.
Key Competencies
- Documentation control
- Regulatory compliance
- Risk management documentation
- QMS documentation and record control
- Audit readiness
- Cross-functional coordination
- Analytical thinking and attention to detail
