12 month hourly contract opportunity for a Quality Engineer looking to join a leading global Cork based Medical Device organisation.
Key Responsibilities:
- Drive adherence to the Quality Management System (QMS) in line with international standards, including ISO 13485 and FDA 21 CFR Part 820 (QSR), and the EU Medical Device Regulation (MDR).
- Lead, investigate, and effectively manage the Corrective and Preventive Action (CAPA) system, including root cause analysis (RCA), action planning, implementation, and verification of effectiveness.
- Own and manage the disposition of non-conforming materials (NCMRs) and product deviations, collaborating with cross-functional teams to resolve issues promptly.
- Define, execute, and approve validation activities for processes and equipment (IQ, OQ, PQ) and test method validations (TMV).
- Support and potentially lead internal audits, as well as actively participate in external audits (e.g., Notified Body, FDA, customer).
- Champion and implement continuous improvement initiatives on the manufacturing floor and within the QMS using methodologies such as Six Sigma, Lean Manufacturing, and SPC (Statistical Process Control).
Skills, Attributes & Experience:
- Degree in Engineering, Science or related discipline
- Minimum of 2 years + experience working within Medical Device Manufacturing
- Experience working in a Manufacturing, Quality, or new product introduction role is desired
- The successful candidate must demonstrate strong time management and organisational skills.
- Excellent communication is essential.
