A global manufacturer (medical devices) are currently looking for a Manufacturing Quality Engineer to join their team in Boyle, Co. Roscommon.
The Manufacturing Quality Engineer will be responsible for ensuring manufacturing processes, products and systems are in compliance with requirements.
Key Responsibilities (Full job description available on request):
- Act as the Manufacturing Lead with respect to process monitoring and key quality control points ensuring negative trends are addressed.
- Ensure that all products manufactured meet the specifications, performance & quality criteria of end users, customers, regulatory authorities and the company.
- Process Audits of the manufacturing lines to ensure the product being manufactured and the equipment and process comply with all requirements.
- In conjunction with the Manufacturing Engineer, provide product line support for the production department, approve documentation for extrusion equipment and process and execute validations for product process and technology.
- Identify and suggest improvements to current equipment, processes, and procedures to deputize for our Site Quality manager in his/her absence.
- Degree or equivalent in Engineering/ Quality or Science discipline or equivalent in Polymer, Manufacturing or Mechanical Engineering.
- Medical device manufacturing experience is essential.
- Manufacturing, Engineering or Process Quality experience in similar position (4 plus years beneficial).
- Good working knowledge of production and quality system requirements in the health care industry (13485 and FDA QSR Parts 820) required.
For a confidential discussion and more information on the role, please contact Sarah Flynn