Your Job As a Quality Engineer you will ensure compliance with the Quality management systems in place (ISO *****************/ FDA 21CFR Part 820) and other relevant standards.
You will carry out duties in accordance with Quality, Environmental Health and Safety policies and GMP and contribute to the achievement of the company goals and KPI's, including analysis of data for continual improvement.
Our Team Working as part of a dynamic Quality team of 3 Quality Engineers,1 Batch Release specialist and 5 Quality Inspectors.
This team has a broad range of knowledge and experience from the longstanding history of the Letterkenny site, its customer base and medical device destinations/uses.
The successful candidate will report to the Quality Manager.
What You Will Do Ensure compliance with the Quality Management Systems in place (ISO ***** and FDA 21CFR Part 820) and other relevant standards (ISO ******************).
Carry out duties in accordance with Quality, Environmental Health and Safety policies of PMLK and GMP.
Contribute to the achievement of the company goals and KPI's, including analysis of data for continual improvement.
Batch review and product release of sterile and non-sterile product.
Non-Conformance Investigations (both Internal and External).
CAPA Management Documentation of Vendor notified changes and progression of changes through to completion where necessary.
Document changes to product via the ERP system.
Liaise with NPI department in relation to component set up and Validation activities, including Protocols and Report reviews and approvals.
Managing and controlling outsourced sterilization and laboratory activities.
Management of Sterilisation revalidation (ETO and GAMMA) Management of Environmental results including data trending and reporting Responsible for self-training on MPS divisional documentation in Molex.edu learning management system.
Active participation in the Quality Culture, CIP and recognition programs.
Who You Are (Basic Qualifications) Quality related discipline qualification.
Proven Quality Engineering experience in the Pharmaceutical/Healthcare manufacturing industry.
Knowledge of Medical Devices, relevant international standards and the FDA requirements.
Thorough knowledge of Quality disciplines, including Quality, Planning, Costs of Quality, Quality Monitoring, Quality Systems and Quality Statistics.
Conversant with the significant aspects of the Medical Device Regulation, ISO *****, / FDA 21 CFR 820 / QMSR and the role of relevant guidance standards.
Additionally, everyone has individual work and personal needs.
We seek to enable the best work environment that helps you and the business work together to produce superior results.
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