An innovative and growing Medical Device company in Co. Offaly is currently seeking an experienced Quality Manager to lead and maintain the company’s Quality System to the highest of standards.
As a Quality Manager, you will report directly to the Plant Manager and will be responsible for the management, direction, and coordination of all quality and regulatory matters on site.
This is a Permanent role with an excellent salary and package.
Your new job
Key duties & responsibilities include:
- Ensure department KPIs are met – safety, quality, complaint analysis, product conformances.
- Ensure achievement of recognised quality standards (ISO13485) and legal compliance.
- Site lead for Regulatory audits.
- Approval of technical transfers and Quality Agreements.
- Audit contractors and suppliers to ensure they comply with company standards.
- Monitor quality data daily and take appropriate action when necessary.
- Lead all elements of Quality Control, document control, validation, calibrations, customer Quality interface and supplier Quality assurance.
- Management of the Quality department including annual goal setting, training and management of Quality standards.
What are we looking for?
- A bachelor’s degree in Quality / Science / Engineering or another relevant technical field.
- 8 + years’ experience in a Quality role within a highly regulated manufacturing facility.
- 5 + years’ experience in a people management role.
- Understanding of common problem-solving tools.
- Experience in Lean Six Sigma with certification required.
- Audit qualification or experience.
- Excellent communication skills – written, verbal and interpersonal.
- Strong ability to interpret and analyse statistics and data.
- Knowledge of FDA/ISO regulations and substantial experience with ISO 9001/13485 highly desirable.
Apply for this job now by sending in a Word version of your CV or get in touch with Oliver at email@example.com
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