Cache of job #13852512

Job Title

Quality Engineer (Med. Dev)

Employer

Sanderson Recruitment Ireland

Location

Westmeath

Description

A key role within quality engineering QMS for Supplier Mgt & compliance related projects, ensuring technical correctness, & compliance with requirements of global regulations and part of an overall strategy for improved quality assurance for QMS, product quality. Reporting to the QA Manager you will : - Monitor current & assess potential new suppliers /service providers for technical, quality , & quality system capabilities. Implement continuous & innovative improvements with demonstrated & measurable results - Cost of Poor Quality etc. Drive supplier audit program by managing & conducting supplier audit s. Ensure proper root cause is found & implemented by supplier. Evaluate nonconforming supplied material & prepared Supplier Correction Action Requests to ensure resolution of root cause causing supplier quality issue. Ensure supplier files are compliant with regs & internal procedures. Partner with Site Purchasing & Divisional Supplier Quality team to ensure cross site competencies & drive improvements. Liaise with Operations, Supply Chain Mgt, Warehouse, Engineering & NPI to ensure uninterrupted supply of material s. Support NPIs by providing guidance on compliance with Company KPIs defined in material specifications, CTQ's, processes quality agreements etc. Ensure that requirements clear in the quality manual & SOPs are adhered too, & provide advice & guidance to all dept's regarding quality. Provide Operational QA Support for products & process. QUALIFICATIONS/EXPERIENCE. Degree in Quality , Engineering or a Science discipline with - 3-5 years' experience at quality engineering level within a regulated industry, ideally in Medical Device. Demonstrable knowledge of FDA 21CFR820 &/or ISO 13485 regulations. Audit experience in conducting supplier & or internal audit s. Certified Lead auditor qualification for ISO13485 is an advantage & statistical methods (FMEA etc. Familiarity with use of ISO 14971:2007 an advantage. Ability to communicate to mgt & peers, both orally & in reports. PERSONAL COMPETENCIES. Good project planning & organisational abilities. Strong interpersonal & communications skills, including oral & written reports. Pro-active with proven ability to work under own initiative, & strong team player. Solid technical ability & willingness to travel as part of duties. Please apply to the role and then we can discuss in detail. This job originally appeared on RecruitIreland.com.

Date Added

2263 days ago

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