Quality Engineer

Actalent • Anoka, MN • 1h ago

Overview

As a Quality Engineer, you will play a critical role in new product introduction, process validation, and manufacturing transfer activities, partnering with engineering, operations, suppliers, and customers to bring products from development into commercial production.

Responsibilities

Represent Quality on cross-functional product development teams.

Support design transfer and product commercialization activities.

Review and approve specifications, validation protocols, engineering changes, and quality documentation.

Lead or support IQ/OQ/PQ validation activities and process qualification efforts.

Facilitate manufacturing transfers between sites, suppliers, and customers.

Drive risk management activities including FMEAs and Control Plans.

Partner with manufacturing and engineering teams to improve process capability and manufacturing readiness.

Support supplier qualification, quality investigations, and continuous improvement initiatives.

Ensure compliance with FDA regulations, quality systems, and applicable industry standards.

Qualifications

Bachelor's degree in Engineering or related technical discipline.

5+ years of Quality Engineering experience within medical device or regulated manufacturing environments.

Experience with new product introduction, design transfer, process validation, and manufacturing transfers.

Strong knowledge of FDA regulations, risk management, CAPA, SPC, FMEA, and root cause analysis tools.

Proficiency with Minitab, JMP, or similar statistical software.

Excellent communication, analytical, and project management skills.

Preferred Qualifications

Medical device CDMO or contract manufacturing experience.

CQE, Lean Six Sigma, or related quality certifications.

Knowledge of cleanroom operations, sterilization processes, and eQMS platforms.

Experience with DOE, measurement system analysis, and process capability studies.

Work Environment

On-site role within a manufacturing and engineering environment. Occasional travel may be required to customer, supplier, or company locations. Exposure to production and plating areas requires adherence to safety and quality procedures.

Job Type & Location

This is a Permanent position based out of Anoka, MN.

Pay and Benefits

The pay range for this position is $95000.00 - $120000.00/yr.

Individual compensation offered for this position within this range will depend on many factors, including qualifications, skills, relevant experience, job knowledge, geographic location, internal equity, and other pertinent job-related factors.

PTO, 401K match, and 10 Paid Holidays

Workplace Type

This is a fully onsite position in Anoka,MN.

Application Deadline

This position is anticipated to close on Sep 6, 2026.

About Actalent

Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 20,000 consultants and 5,000 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500. We are proud to be an Engineering News-Record (ENR) Top 500 Design Firm for our engineering design services and a ClearlyRated Best of Staffing® winner for both client and talent service.

The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

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