Cache of job #13765587

Job Title

QA Engineer

Employer

Hartley People

Location

Waterford, Wexford, Tipperary

Description

Our client, a leading regulated manufacturing company are looking for a QA Engineer to join their team. This is an opportunity to join an established company in a challenging and rewarding role with excellent opportunities for personal development. The Role: Liaise with shift management to manage the Manufacturing operation to provide the required volume output per shift which complies with all quality and regulatory requirements. Determine appropriate lot disposition decisions on a shift by shift basis. Manage, review & approve any non-conformances that may occur. Provide quality oversight for manufacturing, including approval of validation documentation, updating PFMEAs , manage CAPA activity & continuous improvement. Act as the MQM interface with Operations and engineering functions. Disposition product as appropriate & manage any non-conformance activity. Highlight relevant issues and participate / lead resolution. Understand and review Validation documentation, Change Requests, Design and Process FMEA’s. Participate in Quality System Continuous Improvement activities. Ensure regulatory compliance to GMP’s of applicable medical device regulatory agencies (eg, FDA, ISO and MDD) and internal documentation. Provide direction to ensure product quality is maintained at all stages of the manufacturing operation. Additional requirements of the job will be specified by the Manufacturing Quality Manager. The Person: Minimum 3 years’ experience in a regulated pharmaceutical/medical device environment. Manufacturing quality experience desirable. Full understanding of the requirements of the Regulatory Standards. Experience in Quality auditing an advantage. Experience in using Microsoft Office products. Experience of working in a team environment. Third level Qualification in Science or Engineering. Statistics/Six Sigma qualification an advantage. Good communication skills. The ability to motivate and influence people. Self-starter, highly motivated with the ability to prioritize. Strong attention to detail. Hartley People Recruitment work to the highest ethical standards within our industry and we value the trust that you place in us when you send your CV. We can provide a full consultation in confidence and we guarantee that your CV will not be sent to any of our clients without your prior consent. For immediate consideration please call Pairic on 051-878813 or email your CV in response to this job posting. Hartley People also recruit for similar roles such as Analytical Chemist, Quality Control Manager, Quality Control Technician, Quality Assurance Manager, Quality Assurance Technician, New Product Development Manger, Quality Systems Manager, Formulation Scientist, Development Technologist.

Date Added

2469 days ago

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