Quality Engineer - Manufacturing

UFP Technologies•Grand Rapids, MI

2d•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.

Requirements

Bachelors degree or equivalent in quality, operations management or engineering related fields plus a minimum of 3 - 5 years of quality experience in manufacturing environment.
Experience in ISO quality system procedure requirements.

Nice To Haves

Quality Engineer (CQE) certification and/or training a plus.
Available to travel, as needed. Less than 10%.

Responsibilities

Ensures the Quality Management System (QMS) is established, implemented, and maintained in accordance with ISO 13485 and IATF 16949 requirements, as applicable.
Leads and participates in client, customer, and regulatory audits and assessments, including medical device and automotive customers.
Manages the internal audit program in alignment to standards.
Authors, reviews, and approves quality system documentation, including procedures, work instructions, control plans, and records.
Manages corrective and preventive actions (CAPA), ensuring structured problem-solving methodologies (e.g., 8D) are utilized for automotive and medical device requirements.
Serves as a key decision-maker for the quality department, ensuring compliance with customer-specific requirements and regulatory expectations.
Supports and oversees validation activities, process validations (IQ/OQ/PQ) for both medical and automotive products.
Ensures compliance to site-level policies, procedures, and customer-specific requirements (CSRs).
Receives, investigates, and resolves customer feedback, complaints, and returns, including warranty-related concerns for automotive customers.
Performs risk analysis for new and existing products and processes using methodologies such as FMEA (Design and Process).
Maintains company quality standards and ensures alignment with regulatory and automotive customer expectations.
Actively participates in daily production meetings with production, engineering, and leadership teams to drive quality and operational performance.
Maintains awareness of applicable regulatory and industry standards, including FDA, ISO, and IATF requirements.
Drives continuous improvement initiatives using methodologies such as Lean, Six Sigma, and root cause analysis.
Manages non-conformances, deviations, rework, and concession processes, ensuring proper documentation and disposition.
Leads Advanced Product Quality Planning (APQP) activities, including PPAP submissions, control plan development, and production readiness reviews for automotive programs.
Performs all other duties as assigned or needed.