About UFP Technologies:

UFP Technologies is a producer of innovative custom-engineered components, products, and specialty packaging. Using foams, plastics, composites, and natural fiber materials, we design and manufacture a vast range of solutions primarily for the medical, automotive, aerospace & defense, electronics, consumer, and industrial markets. Our team acts as an extension of customers’ in-house research, engineering and manufacturing groups, working closely with them to solve their most complex product and packaging challenges. For our customers, innovation takes many shapes. But each solution is shaped by a level of design, materials and process expertise that is unique to UFP Technologies.

Location: Newburyport, MA

Position Summary:  

Provides quality engineering technical support to the entire business-related to corrective actions, 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.

Essential Duties and Responsibilities:

  • Supports, upholds and enforces compliance to ISO 9001, ISO 13485 and AS9100 regulations.
  • Investigates and documents customer returns and complaints.
  • Implements measurable effective corrective & preventive actions.
  • Provides instruction, guidance and direction for manufacturing, engineering, materials, customers and suppliers in 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 problems.
  • Performs supplier approvals assessments per ASL 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.


Education / Experience:

  • Associate degree in Quality Assurance, Engineering, or Technology, plus 5 years of quality or manufacturing experience. Bachelor’s degree in said fields preferred.
  • Quality Engineer Certification (CQE); plus 7 years’ experience will be considered.
  • Experience in either ISO 13485; ISO 9001; or AS 9100 quality standards is required.
  • Thorough understanding of statistical process control and process capability is required.
  • Cleanroom experience and certification in Geometric Dimensioning & Tolerancing (GD&T), a plus.
  • Cleanroom, cGMP, and/or 21 CFR Part 820 experience, a plus.

Please apply here.

 

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