Our client, a leading company in Limerick, Ireland is recruiting for an quality Systems Supervisor to join their team.
The primary function of this position is to lead engineering participation in post market surveillance (PMS) and participate in projects focused on design and / or process modifications of devices, post release to market, for the purpose of maintaining device quality and compliance.
Reporting to: Senior Sustaining Engineer
- Engineering representative on the PMS team. The qualified candidate for this position should excel in an environment that embraces teamwork, change, risk-based decision making and flexibility. This individual should be willing to make a significant contribution to a cross functional team, must be self-motivated to take action, and have excellent written and verbal communication skills. Candidate will support efforts to ensure Regulatory compliance.
- Evaluation of medical devices regarding their risk potential (based on EN ISO 14971)
- Represent Engineering at cross-functional team meetings
- Provide an Engineering interpretation of the analysis of clinical and non-clinical data pertinent to medical devices (e.g., complaints trends, literature reviews, abstracts, posters, presentations, manuscripts, Clinical Evaluation Reports, and clinical study reports).
- Review trending data and use engineering knowledge and risk based approaches to identify when corrective actions are required.
- Support the post market surveillance of devices in terms of complaint investigation and risk analysis.
- Provide engineering support for post market clinical studies if required.
- Identify and implement updates to risk management and PMS process to ensure regulatory compliance
- Update governing risk management documents (dFMEA/pFMEA) to facilitate post market surveillance feedback
- Ensure effective reporting to the Senior Sustaining Engineers and Sustaining Engineering Manager.
- Work closely to build effective relationships with other functions in particular Production, Quality and Regulatory teams.
- Lead or participate in engineering projects driven by post market surveillance in either design or manufacturing.
- Collaborate with other Sustaining Engineering Teams to ensure the effective completion of all activities associated with a Sustaining Engineering project / objective.
- Other General Responsibilities
- Ensure that all activities are in compliance with:
- Code of Conduct., Quality System requirements and Company HR policies.
- Liaise with other manufacturing facilities as required.
The Ideal Candidate
- Formal science/production/engineering third level qualification and relevant experience in at least one of the following areas : Medical Device Design & Development/ Risk management
- Strong project management skills (proven track record of same desirable)
- Strong interpersonal skills and the ability to communicate across functions.
- Proven problem-solving skills.
- Strong technical writing skills
- Material science or active pharmaceutical ingredient knowledge an advantage.
- Strong engineering ability to understand medical device designs
- Knowledge of clinical trials an advantage.
- Strong written and verbal communication skills are required, as is the ability to effectively communicate with cross-functional teams and program managers.
- Previous medical device experience desirable, in particular with medical device regulations.
- Working knowledge of Design Controls, GMPs, ISO13485 and ISO14971 quality requirements is preferred.
- Good computer skills including knowledge of Microsoft® Office.
- Strong organisational, collaboration, and team building skills.
- High self-motivation.
- Willingness and availability to travel on company business.
For further information on this Quality Supervisor Role role in Limerick please contact Bimi on 0868395533/ Bimi@hero.ie
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