Quality Engineer

Position Summary

Responsible for all quality matters relating to STERIS Laboratories Tullamore assigned in conjunction with the Senior

Quality Manager, EMEA Labs.

Duties

• Work in collaboration with the Lab Operations Management, Laboratory Tech Team, EO TechTeam and the Radiation TechTeam
• Ensure Quality System is in compliance with STERIS procedures, standards and applicable laws
• Ensure that STERIS Health and Safety Policies are correctly implemented and respected in Laboratories
• In collaboration with other departments, initiate, investigate, control and analyze non-conformance reports, complaints, supplier corrective action requests, deviations and OOS (Out of Specification) reports ensuring all relevant parties are informed and where appropriate, ensure appropriate corrective actions are implemented and effective.
• Facilitate Audits (Regulatory Inspections, Notified Body Assessments, Customer Audits, Supplier Audits) in collaboration with Operations Management. Ensure that the internal audit program is executed as per plan and perform audits as required.
• Manage changes to ISO 17025 accreditation scope, new or revised licenses.
• Manage change control in conjunction with lab operations. Ensure new equipment/instruments and quality related software are qualified and requalified either periodically or after modification prior to use.
• Manage and participate in local or global projects in collaboration with other departments and facilities.

Duties - cont'd

• Implement continuous improvement.
• Monitor Laboratories performance through facilitation of quarterly facility management review.
• Facilitate Quality and GMP training of all laboratory personnel; develop, support and maintain the lab employee training program.
• Review technical documents including but not limited to equipment, methods, specifications, supplier technical agreements.
• Review Customer Quality Agreements.
• Provide and maintain service excellence to Customers; provide professionalism and courtesy at high level; attend meetings with the Customers

Education Degree

Required Experience

• Bachelor’s degree in science, preferably microbiology.
• Minimum 3 years of experience in Laboratories activities, preferably in microbiology.
• Minimum 3 years of experience in Quality role
• Working knowledge in a regulated industry within an operations or laboratory setting, preferably ISO 17025. In addition, one of the following: ISO 13485, ISO 9001, or other and quality management certification.
• High school level of English reading, writing and verbal communication skills
• 3 years experience and technical knowledge of equipment qualification
• 3 years experience and technical knowledge of test method validation
• 3 years technical experience working with testing standards

Preferred Experience

• Effective communication skills, be a team player, and can prioritize daily activities and solve problems quickly and accurately.
• Technical and quality writing skills
• Knowledge and/or experience of continuous improvement programs and the medical industry would be a distinct advantage
• Ability to handle data
• Computer use and MS Office competence
• Flexibility, autonomy, accountability
• Maintain good relationship with Lab, QA team, co-workers, and processing facilities

Skills