Quality Systems Expert
The quality systems expert will work in the Quality and Regulatory Affairs teams and be responsible for tasks related to the development and maintenance of quality systems to support the organization.
1. Support the VP of Quality and Regulatory Affairs in developing and maintaining a quality system compliant with ISO 13485:2016 and the quality system regulation 21CFR Part820.
2. Manage the document control function for the group, ensuring all documents are processed consistently and compliantly.
3. Represent the quality function at functional team meetings and provide advice and complete documentation reviews in a timely manner.
4. Participate in risk management processes to ensure all risks are captured in the risk management report and mitigated accordingly.
5. Liaise with technical operations to support the manufacture of devices, ensuring high-quality products are delivered in compliance with procedures and regulations.
6. Prepare quality system metrics for management meetings and reviews.
7. Address customer complaints in compliance with relevant regulations, adhering to vigilance and reporting requirements.
8. Manage and implement the CAPA system, addressing observations comprehensively and documenting root cause analysis.
9. Maintain the internal audit system, completing audits on schedule and addressing non-conformances and recommendations.
10. Support supplier management programs, ensuring sub-contractors, suppliers, and external parties meet quality system requirements.
11. Prepare reports, documents, procedures, specifications, and other technical documents as required.
12. Contribute to the continuous improvement of quality system processes and business practices.
Requirements
This role requires a Bachelor's degree in Science or Engineering. Minimum eight years' experience in a quality engineering or regulatory role is preferred, ideally in the medical device industry.
* Excellent written, interpersonal, and presentation skills.
* A self-starter able to advance company goals with minimal direction.
* Strong communications skills, summarizing information effectively and presenting coherent arguments.
* A solid understanding of team dynamics and ability to participate in high-performing teams.
* Accountability and ownership of decisions, actions, and failures.
* Prioritization and focus on critical objectives amidst multiple project tasks.