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Quality Engineer
Location:
Letterkenny
Description:
Your Job As a Quality Engineer you will ensure compliance with the Quality management systems in place (ISO 13485/15378/14001/ FDA 21CFR Part 820) and other relevant standards. You will carry out duties in accordance with Quality, Environmental Health and Safety policies of PMLK 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 4 Quality Engineers 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 * 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 * Liaise with NPI department in relation to component set up and validation activities and with vendors and customers in relation to Quality related matters. * Managing and controlling outsourced sterilization and laboratory activities. * Management of Sterilisation revalidation (ETO and GAMMA) * Management of Environmental results including data trending and reporting * Active participation in the quality culture, CIP and recognition programs. Who You Are * Degree in Quality, Industrial, or mechanical engineering / science related discipline. * Proven experience in Quality Engineering, Quality Assurance, or a similar role. * Working knowledge of ISO 13485 / FDA 21 CFR 820 * Strong interpersonal skills and project management skills * Strong analytical and problem-solving skills. * Excellent attention to detail in verbal & written communication, with a proven technical protocol & report writing background What Will Put You Ahead * Qualified Auditor to ISO 13485 is desirable, but not essential * Experience in SAP or similar ERP System would be beneficial * Previous experience in Medical device industry * Experience in Injection Moulding processes At Koch companies, we are entrepreneurs. This means we openly challenge the status quo, find new ways to create value and get rewarded for our individual contributions. Any compensation range provided for a role is an estimate determined by available market data. The actual amount may be higher or lower than the range provided considering each candidate's knowledge, skills, abilities, and geographic location. If you have questions, please speak to your recruiter about the flexibility and detail of our compensation philosophy. Who We Are As a Molex company, Phillips-Medisize mobilizes and deploys specialized capabilities and services across highly regulated industries, including health care, regulated consumer, automotive and defense. We design, develop and create innovative and life-changing medical technologies for millions of people around the globe. At Koch, employees are empowered to do what they do best to make life better. Learn how our business philosophy helps employees unleash their potential while creating value for themselves and the company. 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. #LI-JO2
Company:
Phillips-Medisize
Posted:
June 13 on Equest
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More About this Listing: Quality Engineer
Quality Engineer is a Quality Assurance Quality Engineer Job at Phillips-Medisize located in Ireland. Find other listings like Quality Engineer by searching Oodle for Quality Assurance Quality Engineer Jobs.
Quality Engineer is a Quality Assurance Quality Engineer Job at Phillips-Medisize located in Ireland. Find other listings like Quality Engineer by searching Oodle for Quality Assurance Quality Engineer Jobs.