Quality Engineer - Manufacturing
UFP Technologies
Summary
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.
Job description
Quality Engineer Summary
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.
Quality Engineer Duties and 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.
Quality Engineer Qualification 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
Requirements
- Bachelor's degree in science, engineering or equivalent
- 3-7 years 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)
- Strong background in medical device quality assurance and processes
- Experience conducting supplier audits and writing supplier contracts
- Familiarity with statistical analysis
Benefits
- Medical, Dental & Vision
- Life Insurance
- Disability Insurance
- 401(k) Matching
- Paid Time Off
- Paid Holidays
- Employee Discounts
Company overview
UFP Technologies, Inc. is a leading American multinational developer and custom manufacturer specializing in comprehensive solutions for medical devices, sterile packaging, and other highly engineered custom products. Founded in 1963 and headquartered in Newburyport, Massachusetts, the company has evolved into a critical partner in the medical device supply chain, serving most of the world's top medical device manufacturers. UFP Technologies focuses on single-use and single-patient devices and components used across various medical applications including minimally invasive surgery, infection prevention, wound care, wearables, orthopedic soft goods, and orthopedic implants. With over 90% of its revenue derived from MedTech business, the company operates 22 global manufacturing facilities, 6 development centers, and 40 cleanrooms. As a publicly traded company on NASDAQ (UFPT), UFP Technologies combines decades of expertise in medical device design, development, and manufacturing with advanced capabilities in cleanroom production, rapid prototyping, and in-house tooling to accelerate product development and ensure precision manufacturing for its clients.