Quality Engineer (Mayo)
Quality Engineer, Perm role, Co Mayo
This is a critical quality position associated with the operation of a new manufacturing facility located in Mayo, Ireland. The Quality Engineer will report directly into the Quality team based at our corporate headquarters (HQ) in California, with local reporting and support onsite by the Director of Operations – Mayo.
Key Duties (full job spec available upon request)
- Work with the Quality Department in HQ to become familiar and implement all aspects of the QMS at the Castlebar facility.
- Communicate regularly with Quality at HQ to ensure consistent adherence to the company’s QA program.
- Site lead for managing SOPs and Document Control.
- Manage quality training programs at the Mayo site to ensure these effectively mirror what is in place at HQ.
- Provide quality-related training for new employees with respect to quality orientation.
- Interface with MRP/MES systems to control QC/QA functions thereof.
- Work with the production team to be familiar with production processes, components, and finished goods quality attributes, manufacturing records, acceptance, and release criteria of the products to ensure compliance with contract and regulatory specifications.
- Assist in the supervision and/or performing incoming QC on incoming raw materials.
- Supplier Management, working closely with procurement
- Assist with the ongoing certification of the cleanroom manufacturing environments and associated controlled areas.
- Review monthly QBMS compliance reports ensuring compliance.
- Track and trend Quality related programs and KPIs in coordination with HQ.
- Participate in the validation and verification of new equipment and processes.
- Support customer audits and site visits.
- Support pre and post-audit activities.
- The Quality Engineer may be required to spend some time post-hire at the HQ facility. **Note: Any travel will be tentative, and wholly dependent on the evolving Covid-19 situation and travel risks and restrictions.
- Educated to a minimum Level 8 in an Engineering, Science or Quality Assurance discipline
- 2+ years’ experience in an industry-related quality role.
- Experience with cleanroom-based operations, GMP regulations, and production operations is desired.
- Experience working in a highly regulated industry is very beneficial.
- Demonstrated critical and effective decision-making skills with the ability to work on one’s own initiative to resolve competing priorities and with minimum supervision is required.
- Must be proficient with MS Office software including Outlook, Word, and Excel.
- Must possess excellent verbal & written communication skills, which include but are not limited to presentation and organizational skills
- Ability to read and interpret documents in English such as SOPs, safety rules, and quality guidelines.
- Excellent attention to detail.
- Coordinate with other departments to ensure cohesive actions that involve quality control expertise or interaction.
- Be a strong team member with the ability to identify and drive quality improvements.
- Ability to organize and judge priorities and work independently with minimal supervision.
Please contact Elaine Dolan for more information or a confidential discussion.
091 706 718