Our client, a leader in medical science for more than 40 years, are committed to solving the challenges that matter most – united by a deep caring for human life. Their mission is to advance science for life, transforming lives through innovative medical solutions that improve patient lives, create value for their customers, and support employees and the communities in which they operate. This is a Hybrid role.
We have an excellent opportunity for a Senior Supervisor, Design Quality Assurance, to join our clients expanding team. As part of the Design Quality Assurance team, a key role will be to demonstrate commitment to the Quality Policy (patient safety and product quality) by executing sound quality practices and maintaining an effective quality system.
The Design Quality Assurance team supports a wide product portfolio including drug eluting therapies (drug-coated stents and drug-coated balloons), balloon dilatation catheters and cutting balloons for Interventional Cardiology. The successful candidate will lead projects related to the balloon catheter product family (including balloon dilatation catheters, cutting balloons and micro-catheters). They will have supervision responsibility within their reporting structure for a minimum of 3 engineers - providing coaching and mentoring support including assignment and oversight of small to medium projects within the sustaining organization.
The candidate will lead projects to support and post-market surveillance, quality, compliance, material continuity, design Value Improvement Projects (VIPs), ensuring that all design changes are compliant to associated regulations and procedures.
Key Responsibilities:
1. In-depth understanding of requirements and procedures that govern medical device Design Control.
2. In-depth understanding of Design Assurance requirements to ensure project deliverables comply with all internal and regulatory requirements.
3. Provide design quality leadership in the resolution of PIRs, CAPAs, NCEPs, and regulatory requirement changes.
4. Interface with R&D, Regulatory Affairs, Clinical Risk, Medical Safety, and Operations team environments to provide technical and quality systems input.
5. Draws conclusions and makes appropriate decisions from test data using excellent analytical and problem-solving abilities.
6. Lead design change projects including scoping, assessment and implementation, through a combination of individual contribution and providing direction to team members
7. Lead updates to documents within the Risk Management File, such as the Hazard Analysis, Task and Use Error Analysis and Design FMEA.
8. Ensure and maintain regulatory compliance with appropriate guidance documents such as company SOP/WI's and EU/FDA/Global guidelines.
9. Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.
10. Support internal and external regulatory audits as required.
11. Provide support and direction for post market surveillance activities, such as Field Signal Evaluations, assessment of field product performance, NCEPs, Periodic Safety Update Reports (PSURs) and Q&A from regulatory authorities.
12. Provide coaching and development support within their reporting structure, including assignment and oversight of small to medium projects within the sustaining organization.
Education & Experience:
13. NFQ Level 8 qualification in a STEM discipline
14. Min 6 years' experience industry experience; Design Assurance experience would be preferable
15. Experience in areas such as design control, risk management, design change, and standards compliance (to regulatory requirements)
16. Strong leadership, problem-solving, technical capabilities, communication and collaboration skills
17. Proven ability to work well both as part of a team and individually.
18. Is enthusiastic and fully motivated to develop their career, to demonstrate best practices in line with the department and site objectives and continually seeks to drive improvements in product and process quality.
19. Interested in coaching and developing team members