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Senior Manufacturing Quality Engineer

Engineering
Clare
Therese Keohane
Permanent
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Job Reference: JO-2009-65380_1599749111

Summary:

Our Clare based Medical Device client is looking for a Senior Quality Engineer to assist with NPI and Transfer activities as well as ongoing manufacturing.



Responsibilities



  • Evaluating process methods and equipment to meet performance and quality requirements

  • Formulates procedures, specifications, and standards for products and processes.

  • Develops and implements corrective/preventative action plans.

  • Collects and analyzes data for gauge and product evaluation.

  • Identifies critical processes, gauges, procedures, and materials needed for the completion of new products.

  • Performs supplier Desktop Assessments and Supplier Onsite Audits.

  • Assesses and determines validation and verification requirements for Supplier Change Notifications, and drive the Supplier Change Notifications to completion.

  • Ensures that suppliers have necessary information and facilities to deliver quality products to the site

  • Establishing quality plans for equipment and processes for general and specific product performance needs Monitoring performance of processes to a standards Applying ISO and QSR requirements to processes and procedures for the company and outside suppliers

  • Working with suppliers on new product introduction to insure that quality and performance requirements are fulfilled Assisting Manufacturing, Sourcing and Development in the interpretation and application of regulations

  • Basic knowledge of blueprint reading and geometric dimensioning and tolerancing, basic understanding of QSR/ISO regulations, design assurance, FMEA, and product testing methods, and can use optical comparators and CMMs.



Requirements



  • BS. in engineering or an alternative Bachelor's degree program with certification as a quality engineer (e.g. CQE).

  • Certification as a quality engineer (e.g. CQE) or the Reliability Engineer Certification (CRE) granted through the American Society of Quality (ASQ) preferred.

  • 5+ years experience in a Quality Engineering role; Medical device strongly preferred, or an equivalent combination of education and experience.

  • Ability to work within a team environment and build relationships outside of the department as well as outside the company (suppliers, regulatory agencies, etc.).

  • Facilitates team efforts on quality engineering projects.

  • Ability to deliver, meet deadlines and have results orientation.

  • Able to communicate both orally and in written form to multiple levels of the company.

  • Microsoft Office Suite, expert knowledge of blueprint reading and geometric dimensioning and tolerancing, understanding of QSR/ISO regulations, design assurance, FMEA, and product testing methods, and are able to use optical comparators and CMMs.



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Talent Consultant:
Therese Keohane
Therese Keohane
Business Unit Lead
Quality & Laboratory
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