Quality Engineer
My client are now seeking a Quality Engineer to join their Quality team at their Cork facility. In this role, you'll provide critical QA support to Operations and play an important part in ensuring the site meets its quality, compliance, and performance goals.
Key Responsibilities
- Lead and deliver process improvement initiatives across multiple product lines (e.g., yield enhancement, risk reduction, cost-saving initiatives, automation, and error-proofing).
- Provide timely and effective QA support to Operations, ensuring quality, output, and cost targets are achieved.
- Ensure process variables and interactions are clearly defined and verified; support the identification and mitigation of process failure modes (e.g., FMEAs, DOE studies).
- Contribute to ongoing improvements of the site's Quality Management System.
- Ensure full compliance with relevant medical device regulatory standards and cGMP requirements
- Oversee the Incoming Inspection function to ensure efficient flow of materials to production.
- Act as a subject matter expert to other departments on quality, regulatory, and statistical matters.
- Review and approve process and quality system change requests.
- Prepare required regulatory documentation (Technical Files, Design Dossiers, product transfer documentation, etc.).
- Support MRB activities, including trend analysis and corrective action identification.
- Participate in internal quality audits.
- Contribute to Lean Manufacturing initiatives across the site.
Education & Experience
- Bachelor's degree in Engineering, Science, or a related technical field (required).
- 2-3 years' experience in a manufacturing environment, ideally with direct exposure to quality operations in a regulated (GMP) setting.
Experience within the medical device industry is a distinct advantage.
