Associate Quality Engineer

UFP Technologies•Chicopee, MA

7d•Onsite

About The Position

UFP Technologies is a designer and custom manufacturer of comprehensive solutions for medical devices, sterile packaging, and other highly engineered custom products. UFP is an important link in the medical device supply chain and a valued outsource partner to most of the top medical device manufacturers in the world. The Company’s single-use and single-patient devices and components are used in a wide range of medical devices and packaging for minimally invasive surgery, infection prevention, wound care, wearables, orthopedic soft goods, and orthopedic implants. The Associate Quality Engineer will provide technical support to Quality, Manufacturing, and Engineering in measuring, testing, and analytical evaluations of products and processes. This position will support process and planning decisions with knowledge and explanations of Quality Engineering policies, practices, and procedures.

Requirements

Bachelor’s degree in Engineering or Technology.
2 years of experience in quality assurance in a manufacturing environment (preferably ISO 9001 or ISO 13485).
Demonstrated knowledge of statistical process control and process capability.

Nice To Haves

Certification in Geometric Dimensioning & Tolerancing (GD&T), a plus.
Cleanroom, cGMP, and/or 21 CFR Part 820 experience, a plus.

Responsibilities

Performs general GD&T analysis and interpretation to support engineering and manufacturing activities.
Conducts part and process qualification to ensure products meet required specifications.
Executes Gage R&R studies to assess measurement system capability.
Evaluates and dispositions non-conforming material in accordance with quality standards.
Performs First Article Inspections (FAI) to support product validations.
Participates in New Product Introduction (NPI) projects to ensure quality requirements are met.
Ensures compliance with Quality Management System (QMS) procedures and process standards.
Supports process development initiatives and continuous improvement activities.
Reviews engineering and quality documentation for accuracy, completeness, and compliance.
Participates in IQ, OQ, PQ, and PPAP activities as required.
Identify and propose cost-saving opportunities and quality improvement ideas.
Contribute to ongoing business and service improvements.
Support program launches by providing quality and technical expertise.
Assist with the metrology and calibration program as needed.
Support product development efforts and production transfer activities.
Perform other related duties as required or assigned based on business needs.