Quality Engineer - Manufacturing

UFP Technologies•St. Charles, IL

2d•$80,000 - $100,000•Onsite

About The Position

This position ensures that the quality related engineering needs of the organization are met. Responsibilities include compliance and risk analysis, process validation, pFEMA’s, IQ, OQ, PQ and PPQ validation, CAPA and etc. Position works in collaboration with operations, supply chain, new product development teams.

Requirements

A Bachelor's degree in science, engineering or equivalent
3-7 year’s relevant experience
At least 3 years’ experience in medical device manufacturing
Strong knowledge of Quality Systems policies and regulations (ISO 13485 and FDA Part 820) with a strong background in medical device quality assurance and processes
Experience conducting supplier audits and writing supplier contracts
Familiarity with statistical analysis

Responsibilities

Lead in supporting compliance for medical device manufacturer in ID/Traceability throughout supply chain, well documented and executed Acceptance Activities, Non-conforming material management, Packaging/Labeling control, Production/Process controls, Process Validation.
Risk Assessments, project meetings, pilot builds, First Article Inspections, and Post Market Risk Management
Designs and implements methods and procedures for inspecting, testing and evaluating the precision and accuracy of products and/or production equipment
Design and execution of pFEMA’s, IQ, OQ, PQ and PPQ validation
Corrective and Preventive Action management, facilitation, ownership and problem resolution
Process improvement and support, including Quality System process review and revision
Training assistance, including providing training in quality system activities/requirements
Internal and external audit coordination and facilitation
Performs all other duties as needed.