Cache of job #14033983

Job Title

Shift Quality Engineer

Employer

ICDS Recruitment

Location

Waterford

Description

Shift Quality Engineer. Key Purpose: The ideal candidate will liaise with shift management to manage the Manufacturing operation to result in providing the required volume output per shift which complies with all quality and regulatory requirements. Manufacturing performance will be kept on an absolute optimum level to deal with output production, the ideal candidate will be responsible for this. Principal Responsibilities of this position: 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 PFMEA's, 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. Minimum Qualifications & Experience: 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 prioritise. High attention to detail. This job originally appeared on RecruitIreland.com.

Date Added

1750 days ago

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