The QA Associate is responsible for supporting the maintenance and continuous improvement of the Quality Management System (QMS) in compliance with applicable regulatory standards (e.g., ISO 13485, FDA 21 CFR Part 820, EU MDR, and other regional requirements).
This role ensures that quality processes are effectively implemented across operations, manufacturing, supply chain, and product development to support regulatory compliance and business objectives.
Key Responsibilities 1. Quality Management System (QMS) Support
* Maintain and update QMS documentation, including SOPs, work instructions, forms, and records
* Ensure document control processes are properly followed
* Support internal audits and ensure audit readiness at all times
* Assist in preparation for external audits (e.g., ISO, notified body, regulatory inspections
2. CAPA & Non-Conformance Management
* Support investigation and documentation of non-conformances
* Assist in root cause analysis and implementation of corrective and preventive actions (CAPAs)
* Track CAPA effectiveness and closure timelines
* Ensure proper documentation and traceability
* Assist with supplier qualification and monitoring
* Support supplier audits and performance evaluation
* Review incoming inspection records and quality documentation
4. Product & Process Quality
* Support QA release activities for finished goods (e.g., culture media, instruments)
* Assist with risk management documentation (FMEA, risk files)
* Participate in design control documentation and DHF maintenance
* Support validation activities (process validation, equipment validation, cleaning validation as applicable)
5. Regulatory & Compliance Support
* Maintain training records and ensure employee training compliance
* Support regulatory documentation preparation where required
* Assist with complaint handling and post-market surveillance documentation
* Identify opportunities for process improvement within the QMS
* Support quality metrics reporting (KPIs such as NC rate, CAPA closure rate, audit findings)
Qualifications & Experience
* Bachelor's degree in Life Sciences, Engineering, Biotechnology, or related field
* 1–3 years of experience in QA within medical devices, IVF, biotech, or regulated manufacturing environment preferred
* Working knowledge of ISO 13485 and/or FDA QSR requirements
* Experience with document control systems and electronic QMS tools preferred
* Strong attention to detail and organizational skills
* Excellent written and verbal communication skills
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