Quality Engineer

Pe Global

Sligo

POSITION SUMMARY: To ensure that product manufactured at the site complies with approved specifications and that activities at the site comply with current good manufacturing practice and Regulatory Agency requirements. GENERAL SCOPE OF RESPONSIBILITIES: Coordinating appropriate assigned elements of the Quality System, ensuring full compliance by all relevant plant personnel with its requirements. Audit the quality system with other management personnel where required. Assist in the investigation and coordination of customer complaints and assess need for implementation of effective corrective or preventive actions. Manage day-to-day CAPA requirements by ensuring timely and effective initiation, investigation, correction and corrective actions. Measure performance of the Quality System and providing metrics, for inclusion in the management review, monthly reports etc. Verification of effectiveness of corrective/preventive actions arising out of product process and quality system non-compliance. Ensure implementation and compliance with relevant Regulatory requirements. Inspect incoming product and manage the supplier Quality relationship. Comply with the EHS policy and procedures and demonstrate EHS best practices in all work activities. QUALIFICATIONS AND EXPERIENCE: 2 year plus experience in the day-to-day operation of the quality system in a highly regulated combination product/device manufacturing environment. Minimum 2 years working knowledge of quality systems regulations (ISO13485/ISO9000; CFR 21 Part 820) or individual elements within the regulations such as; process validation, design controls, CAPA, auditing, etc., is desirable. Experience in an injection moulding or tooling environment is desirable. Green Belt qualified or demonstrated knowledge of statistics in an industrial environment is desirable. Degree in an Engineering, Science, Quality or other discipline with suitableexperience as deemed suitable by Quality Manager. ESSENTIAL: •Minimum 2 years working knowledge of quality systems regulations (ISO13485/ISO9000; CFR 21 Part 820) or individual elements within the regulations such as; process validation, design controls, CAPA, auditing, etc., is desirable. Please call Lisa O'Sullivan on 021 4297 900 for more info or email your up to date CV to lisa.osullivan@peglobal.net. Quality Engineer, Job, Sligo. This job originally appeared on RecruitIreland.com.

2647 days ago