Quality Engineer

About UFP Med Tech:

UFP Technologies is a designer and custom manufacturer of comprehensive solutions for medical devices, sterile packaging, and other highly engineered custom products. UFP is an important link in the medical device supply chain and a valued outsource partner to most of the top medical device manufacturers in the world. The Company's single-use and single-patient devices and components are used in a wide range of medical devices and packaging for minimally invasive surgery, infection prevention, wound care, wearables, orthopedic soft goods, and orthopedic implants.

• Medical, Dental, Vision, Life, Disability Insurance
• 401K with a matching contribution
• Paid time off, Paid holidays, Employee discounts and much more!

This position will be on-site full-time in Chicopee, MA. The position holder will need to be within commuting distance (within 45 min).

Applicants must be authorized to work for any employer in the U.S. At this time, we are unable to sponsor or assume sponsorship of an employment visa.

The Quality Engineer has the responsibility for the development and implementation of quality systems for sealed plastic film products in an ISO 13485 environment involving contract manufacturing of medical devices.

• Provides oversight and approval of IQ, OQ, PQ validation protocols, execution and reports on new and sustaining products.
• Oversees PPAP activities and produces PPAP submittal packages on new and sustaining products.
• Participates as a member of the FMEA team related to primarily new and developing products.
• Develops and documents control plans.
• Conducts statistical capability studies and sets up SPC control charts.
• Documents inspection procedures and test methods.
• Performs regular audits of processes and materials to ensure that inspections, tests, and operations are being conducted and documented according to applicable specifications and standard operating procedures; assures the results of inspections and tests are in compliance with all applicable requirements.
• Monitors final release of finished product based on above audits.
• Monitors and interprets SPC charts to assure that processes remain in control.
• Directly interfaces with production in the operator training process for quality issues.
• Reviews reject reports and initiates corrective action as required.
• Directly interfaces with other support departments as required.
• Completes special testing when required for failure analysis, validations, etc.
• Sets up inspection/test equipment.
• Observes all safety regulations and procedures.
• Follows all department and company policies and procedures.
• Performs other similar duties as required by responsibility, necessity or as requested.

• 4 year college degree in related field and 2+ years' experience in a Quality Engineering Role (preferably in medical device manufacturing) or equivalent combination of education and experience.
• Experienced in IQ, OQ, PQ validations.
• Good working knowledge of ISO 13485, PPAP, FMEA, AIAG Control Plan Methodology, and SPC.
• ASQC Certified Quality Engineer preferred.
• Good computer skills.
• Ability to interact with all levels of the organization and with suppliers.
• Strong written and oral communication skills.
• Strong analytical skills in problem analysis and problem solving.
• Occasional travel may be required.

UFP Technologies, Inc. is an Equal Opportunity/Affirmative Action employer Minorities/Women/Veterans/Disabled.

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