Quality Analyst Job (Part time)

Key responsibilities:

1. Conduct visual, dimensional, and functional inspection of surgical instruments using calipers, micrometers, gauges, and optical tools
2. Review and maintain Device History Records (DHR) and Device Master Records (DMR)
3. Perform incoming inspection of raw materials and outsourced components
4. Document and report non-conformances, initiate CAPAs, and support root cause analysis
5. Ensure compliance with ISO 13485, ISO 14971, FDA 21 CFR Part 820, and EU MDR requirements
6. Support process validation and qualification (IQ/OQ/PQ) for manufacturing and sterilization processes
7. Assist with internal and external audits, including FDA and ISO inspections
8. Review and approve supplier quality documentation and collaborate with the supply chain team
9. Maintain accurate and timely quality records in QMS and ERP systems
10. Contribute to continuous improvement initiatives across the QA department

Requirements:

1. Hold a bachelor's degree in engineering, life sciences, or a related field
2. Possess 2-5 years of QA experience in the medical device industry (preferably surgical tools)
3. Demonstrate working knowledge of ISO 13485, FDA QSR, and EU MDR
4. Be proficient with inspection tools and GD\&T
5. Be familiar with CAPA, FMEA, SPC, and risk management
6. Show strong documentation and attention to detail
7. Have experience with QMS software (e.g., MasterControl, Greenlight Guru)
8. Exhibit excellent communication and collaboration skills

2