Design Quality Engineer
Consultant, Medical Devices, Design Quality Engineer
Our client, a global medical device manufacturer, identify a design quality engineer to assist with a new integration project to assure that our client’s products, processes, procedures, and systems continue to comply with regulatory requirements as they are submitted for approval to regulatory bodies.
Duties / Expectations of Role
· Responsible for assuring products conform to established requirements and standards through appropriate audit, inspection, and test activities. Interacts with many different functional departments and suppliers.
· Formulates procedures, specifications, and standards such as:
· Review/approve prints
· Review/ inputs to design inputs, outputs, verification and validation
· Define critical features for inspection
· Define inspection method and sample size
· Define/ approve First article layout
· Design control transfer
· Review/ approve PPAP+ documents from vendors (defining requirements for qualifying production process with vendors)
· Develops and implements corrective/preventative action plans.
· Collects and analyzes data for gauge and product evaluation.
· Identifies critical personnel, gauges, procedures, and materials needed for the completion of new products.
· Ensures that suppliers have necessary information and facilities to deliver quality products to client.
· Leading/coordinating inspection of verification/validation samples
· Review/approve tolerance analysis
· Work with person to create CMM program
· Create overlays
· Ideally create gage designs (or at least review/approve) & Gage R&R
· Review/approve mold tooling qualification
· B.S. in engineering or an alternative Bachelor’s degree program with certification as a quality engineer (e.g. CQE).
· 5+ years of work experience including 3 or more years of relevant quality system experience in a medical device manufacturer.
· Certified Quality Engineer (CQE) and Medical device, particularly Orthopedic industry, experience preferred
· Ability to work within a team environment and build relationships outside of the department as well as outside the company (suppliers, regulatory agencies, etc.).
· Ability to deliver, meet deadlines and have results orientation.
· Able to communicate both orally and in written form to multiple levels of the company.
· Demonstrates characteristics of high potential for future development opportunities.
· Microsoft Office Suite
· Basic knowledge of blueprint reading and geometric dimensioning and tolerancing, basic understanding of QSR/ISO regulations, design assurance, FMEA, and product testing methods, and are able to use optical comparators and CMMs.
Term & Start
· 18+ months
· Start ASAP
· Onsite in Northern OH or Northern CA