UFP Technologies Hiring for Quality Assurance Engineer Full Time

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!

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

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.

To apply for this job please create a profile with us through our online application system. Click the “Apply” box in the upper right-hand corner to start the application process. Or, if you already have a social media account with LinkedIn, Google, or Facebook you can use your log in credentials to apply.

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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