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About UFP MedTech:

UFP MedTech, a UFP Technologies, Inc (Nasdaq:UFPT) business, offers a full suite of design, development, process, and manufacturing services for single-use and single patient medical devices. We create OEM devices, subassemblies, components and packaging, from Innovation to Manufacturing, using a differentiated flexible materials portfolio with best-in-class operational excellence systems to improve patient outcomes for our clients.

Our culture is centered around innovation, collaboration, creativity, and service. This is the connective tissue that drives our pursuit of industry leadership and customer partnerships throughout our organization.

UFP Technologies, Inc. offers a competitive benefits package, including but not limited to:

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

Position Location: Chicopee, MA

Summary: 

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 multiple industries.

Essential Duties and Responsibilities:

  • Provides oversight and approval of IQ, OQ, PQ validation protocols, execution and reports on new and sustaining products.
  • Oversees PPAP activities and produce 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 initiate 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.

Education / Experience:

  • 4 year college degree in related field.
  • 2 - 3 years of Quality Engineering experience preferred.
  • 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.

For more information on UFP MedTech, visit www.ufpmedtech.com.

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

 

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