Quality Engineer

Actalent; Anoka (MN); On-site; USD 95,000 - 120,000; Full time

Job summary

Actalent is seeking a Quality Engineer in Anoka, MN, to drive new product introduction, design transfer, and manufacturing transfer activities within a regulated medical device environment.

The role focuses on project management, CAPA, FMEA/DOE, and ensuring compliance with FDA regulations while collaborating with engineering, operations, and suppliers to enable a smooth transition from development to production.

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.

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.

Skills

FDA Regulations

Risk Management

CAPA

SPC

FMEA

Root Cause Analysis

Project Management

Communication

Quality Engineering

DOE

MSA

Education

Bachelor's degree in Engineering or related technical discipline

Tools

Minitab

JMP

Job description

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.

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.

If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email [e-mail] for other accommodation options.

San Francisco Fair Chance Ordinance

Pursuant to the San Francisco Fair Chance Ordinance, for all positions located in the city and county of San Francisco, we will consider for employment qualified applicants with arrest and conviction records.

Massachusetts Lie Detector

It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.

Use of Artificial Intelligence (AI)

We may use Artificial Intelligence (AI) to support parts of our hiring process, including sourcing, screening, and evaluating candidates. AI helps assess applications and qualifications, but final decisions are made by our hiring team. By applying, you acknowledge and agree that your application may be reviewed using AI tools.