Quality Assurance Specialist

1 day ago


Newburyport, Massachusetts, United States UFP Technologies Full time
Job Title: Quality Engineer

UFP Technologies is a leading designer and custom manufacturer of comprehensive solutions for medical devices, sterile packaging, and other highly engineered custom products. We are seeking a Quality Engineer to join our team in Newburyport, MA.

Job Summary:

The Quality Engineer will provide technical support to Quality, Manufacturing, and R&D Engineers in corrective actions, investigation of nonconforming product, process control, statistical analysis, customer complaints, component validation, product measurement and testing, product launch in a cGMP & GDP environment, product certification, ISO 9001, ISO 13485, and AS 9100 audits.

Key Responsibilities:
  • Supports, upholds and enforces compliance with ISO 9001, ISO 13485 and AS9100 regulations.
  • Investigates and documents customer returns, complaints and nonconforming products.
  • Implements measurable, effective corrective & preventive actions.
  • Provides instruction, guidance and direction for manufacturing, engineering, materials, customers and suppliers in quality performance measurement.
  • Provides program launch support at UFPT and customer facilities.
  • Contributes to Lean Manufacturing and 5-S initiatives.
  • Establishes and supports metrology & calibration program.
  • Supports manufacturing and engineering problem solving efforts on in-process and vendor related quality events.
  • Performs supplier approvals assessments per Approved Supplier List requirements.
  • Supports product development and production transfer activities.
  • Translates product requirements into inspection criteria and process capability.
  • Supports QMS internal audits and supplier / customer site audits.
  • Writes work instructions and procedures.
  • Improves and monitors inspection processes.
  • Supports ISO 9001, ISO 13485, and AS 9100 certifications.
  • Supports Project Leader's in performing FAIs.
  • Generates bright cost saving / quality improving ideas.
  • Continuously explores new ways to improve our business and services.
Requirements:
  • Bachelor's degree in Quality Assurance, Engineering, or Technology, plus 5 years of quality or manufacturing experience in regulated industry (i.e. Medical Device or Pharmaceutical).
  • Quality Engineer Certification (CQE); plus 10 years' experience will be considered.
  • Experience in ISO 13485 and 21 CFR Part 820 required.
  • Experience in ISO 9001; or AS 9100 preferred.
  • Thorough understanding of statistical process control and process capability is required.
  • Cleanroom experience is required.
  • Certification in Geometric Dimensioning & Tolerancing (GD&T) is preferred.
  • cGMP experience is preferred.
  • Occasional travel may be required.


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