Job Overview:
The ideal candidate will possess a strong background in quality assurance, with experience in implementing and maintaining quality management systems.
Key Responsibilities:
1. Ensure compliance with medical device regulations, including the Medical Device Directive 93/42/EEC, Medical Device Regulation 2017/745, FDA Quality System Regulations 21 CFR § 820 & 803, ISO 13485, ISO 14971, and Japanese Ministerial Ordinance # 169.
2. Maintenance and continuous improvement of quality management systems to ensure adherence to regulatory requirements.
3. Coordinate CAPA, complaints, and temporary authorization processes to support owners in meeting required timelines.
4. Review and approval of non-conformance, CAPA, and complaint investigation reports.
5. Coordinate audit management process and manage annual audit schedule.
6. Manage quality systems data collection and analysis for timely generation of monthly reports.
7. Prepare and present quality system performance data to management.
8. Generate quality systems data for post-market surveillance purposes.
9. Provide quality oversight and promote quality improvements across departments.
10. Review quality management system documentation as required.
Requirements:
* Educated to diploma level in engineering, science, or quality assurance discipline.
* Training in quality systems, complaints, and CAPA is highly desirable.
* A minimum of five years' relevant experience in the medical device industry.
* Familiarity with ISO 13485, ISO 14971, Medical Device Regulation 2017/745, and FDA QSRs is required.
* Experience in managing quality systems activities is desirable.