A medical device SME is looking to hire an experienced Quality System Engineer in Galway to establish and maintain effective quality system structures to ensure consistent implementation of quality systems in the organisation.
- A leader and expert in the areas of quality systems, applicable medical device ISO standards, including ISO13485:2016 & ISO14971:2007 and Medical Device Regulations
- Constantly promotes awareness of best industry practices making appropriate decisions on a daily basis.
- Champions continuous improvement from a quality system perspective and educates functional areas on quality system requirements.
- Implementation of internal requirements and external laws, regulations, guidance’s and standards, as applicable to the company’s quality systems.
- Under the direction of the Senior Quality Manager, you will lead and manage the alignment of the QMS to the requirements of ISO13485:2016 & 21CFR820.
- Participate cross-functionally and across the business to standardize and continually improve the Quality System policies and procedures.
- Support Regulatory Inspections and Notified Body audits.
- Responsible for compiling Management Review data, Quality metrics and driving continuous improvements in the quality system.
- Responsible for the Internal Audit process, CAPA & non-conformance processes and Complaints process within the organization.
- Conducting internal audits to schedule and maintaining/supporting the supplier quality management process.
Skills, Qualifications & Experience
- Ideally will possess Degree/Post-Grad in Quality Management
- 5+ years’ experience in a medical device manufacturing environment with direct experience in a Quality Systems role and with exposure to FDA / ISO13485 / CE Registration Process.
- Experience with involvement in Regulatory submissions would be an advantage.
- Experience with involvement in design/process validations and FMEAs would be a distinct advantage.
- Lead Auditor or Internal Auditor certification an advantage.
- Excellent interpersonal and communication skills.
- Experience / training in a problem-solving and clinical environment considered a plus.
What you will get in return
- Competitive salary plus a bonus and healthcare scheme
- Fantastic opportunity to work in a growing business
Please get in touch to find out more information
091 706 718