Quality Systems Specialist

UFP Technologies
Newburyport, MA
Job Description
UFP Technologies is a designer and custom manufacturer of comprehensive solutions for medical devices, sterile packaging, and other highly engineered custom products. The Quality Systems Specialist will provide quality systems support to Quality, Manufacturing, and R&D Engineers in QMS improvements, corrective and preventive actions, customer complaints, general project management and audits.

Requirements

  • Bachelor’s degree in Quality Assurance, Engineering, or Technology
  • 5 years of experience in a quality systems or manufacturing environment in a regulated environment (medical device preferred)
  • Experience with 21 CFR Part 820 and ISO 13485
  • Project Management experience (preferred)
  • Experience participating in external / internal audits
  • CAPA resolution expertise
  • Experienced at writing technical documents

Benefits

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