Job Reference: JO-2009-65380_1599749111
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.
- 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.
- 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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