SEDA Talent
Senior Quality Engineer
SEDA Talent are supporting an innovative Medical Device CMO to recruit a Senior Quality Engineer to join their team in Waterford.
If you are an experienced Quality Engineer with a desire to work with a company who partner with industry leaders and innovators and help develop the medical devices of the future that save and improve peoples lives, then this may be the role for you.
THE ROLE
- You will aim to ensure that the quality activities relating to the organisation are fit for purpose and consistently meet both internal and external requirements.
- Remain up to date with ISO and FDA requirements, ensuring the company is audit ready.
- Quality Operations oversight with responsibility for developing and maintaining processes in compliance with QMS and Customer Requirements.
- Supporting and leading teams during QMS investigations (e.g., Non-Conformance Reports), providing review and approval of associated reports and actions within a timely manner.
- Participating in and leading (if required) external audits/inspections (Notified Body Audits / Customer Audits / Regulatory Inspections).
- Supporting compliance with Customer requirements relating to Quality, including oversight of the Complaints and Customer Feedback process.
- Maintenance of Quality Metric Logs with respect to Quality Operations.
- Support HR department with Training Management and reporting of associated metrics.
- Responsible for leading improvement initiatives relating to Quality and Compliance across the site in conjunction with associated departments.
The Person
- 5+ years of quality experience in a regulated environment (contract manufacturing desirable)
- A minimum of 3 years’ U/HPLC experience within a GXP Laboratory environment.
- Experience in Quality Systems Development and Management
- Experience leading and developing teams.
Benefits:
Salary €65k, Pension, Death in service, Disability cover, Health insurance, Performance Bonus
For further details please apply below or call Darrach on 00353576 9941
