Welch Fluorocarbon Inc. · 1 day ago
Quality Engineer
St Charles, IL, US
Full-time
Onsite
Senior Level, Lead/Staff
$90K/yr - $120K/yr
10+ years expWelch Fluorocarbon Inc. is a leader in developing and manufacturing single use safe patient handling systems. The Quality Engineer position ensures that the quality-related engineering needs of the organization are met, working collaboratively with operations and product development teams.
ChemicalHealth CareManufacturingMedical DevicePlastics and Rubber Manufacturing
No H1B
Responsibilities
Leads 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, and Process Validation
Conducts 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
Designs and executes pFEMAs and validations protocols including IQ, OQ, PQ and PPQ
Performs Corrective and Preventive Action management, facilitation, ownership and problem resolution
Drives process improvement and support, including Quality System process review and revision
Provides training assistance, including providing training in quality system activities / requirements
Coordinates and Facilitates internal and external audit coordination and facilitation
Performs all other duties as assigned or needed
Qualification
Required
A bachelor's degree in science, engineering or equivalent
10 or more year's relevant experience
At least 5 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
Company
Welch Fluorocarbon Inc.
For over 35 years, Welch Fluorocarbon has specialized in providing thermoformed components to the medical industry by utilizing thin high performance films.
11-50 employees
Funding
Current Stage
Early StageTotal Funding
unknown2024-07-16Acquired
Leadership Team
Kevin Wiley
Co-Owner & CEO
Darleen Clancy Raber
Human Resources Business Partner
Recent News
2025-07-15
GlobeNewswire News Room
2024-11-19
Company data provided by crunchbase