Quality Engineer

Job Title: Quality Engineer Job Description This Quality Engineer role provides technical and quality engineering leadership within a medical device manufacturing environment, focusing on extrusion, metals, and plastics. The position develops, implements, and maintains quality engineering methodologies, systems, and practices that meet internal, customer, and regulatory requirements. You support product development and manufacturing operations in a regulated setting, ensuring compliance with FDA quality system requirements and ISO-based quality management systems while driving continuous improvement and manufacturing excellence. Responsibilities

- Provide quality engineering leadership in the development, implementation, and maintenance of quality engineering methodologies, systems, and practices that meet internal, customer, and regulatory requirements.
- Support medical device manufacturing operations, including extrusion, metals, and plastics processes, by ensuring robust quality controls and compliance with applicable standards.
- Lead and execute process validation activities, including validation planning, documentation, and reporting, to ensure manufacturing processes consistently produce products that meet specifications.
- Apply statistical quality methods to monitor, analyze, and improve product and process performance in a regulated environment.
- Support product development activities by providing quality engineering input, risk assessment, and design for quality considerations throughout the product lifecycle.
- Maintain and improve the quality management system, including adherence to ISO standards and FDA quality system requirements.
- Lead and participate in CAPA (Corrective and Preventive Action) activities, including problem solving, root cause analysis, and implementation of effective corrective actions.
- Prepare, review, and maintain technical documentation and quality records in accordance with regulatory, customer, and internal requirements.
- Collaborate cross-functionally with manufacturing, engineering, supply chain, and other teams to drive operational and commercial success in the medical device industry.
- Support supplier quality activities, including evaluation of supplier performance and quality-related issues, to ensure incoming materials meet required standards.
- Manage and participate in quality-related projects, ensuring deliverables are completed on time, within scope, and in compliance with regulatory and customer expectations.
- Communicate quality expectations, findings, and recommendations clearly to stakeholders at all levels and contribute to building strategic customer partnerships.
- Demonstrate strong attention to detail in reviewing data, documentation, and processes to identify risks, nonconformities, and opportunities for improvement.

Essential Skills

- Bachelor’s degree in Engineering or a related technical field.
- Experience in medical device manufacturing within a regulated environment.
- Experience with process validation, including validation planning and execution.
- Experience with statistical quality methods applied to manufacturing and product quality.
- Working knowledge of FDA quality system requirements.
- Working knowledge of ISO-based quality management systems.
- Quality engineering experience supporting product development and manufacturing operations.
- Demonstrated quality engineering leadership in a manufacturing or medical device setting.
- Experience with CAPA processes, including problem solving and root cause analysis.
- Ability to prepare and maintain technical documentation and quality records.
- Strong project management abilities to lead and support quality-related projects.
- Proven cross-functional collaboration skills with engineering, manufacturing, and other teams.
- Effective written and verbal communication skills.
- High level of attention to detail in technical and quality-related work.

Additional Skills & Qualifications

- Experience in supplier quality within the medical device industry.
- Experience in extrusion processes and plastics engineering.
- Experience with metals and plastics manufacturing for medical devices.
- Knowledge of quality assurance and quality management principles.
- Familiarity with quality management systems and ISO compliance.
- Ability to build strategic customer partnerships and support commercial success.
- Strong problem-solving mindset and continuous improvement orientation.

Work Environment This role is based in a brand-new facility in Brooklyn Park that features large, clean rooms designed for medical device manufacturing and quality operations. The environment supports work with advanced extrusion, metals, and plastics technologies under regulated conditions and established quality management systems. Team members work in a collaborative, growth-oriented culture that focuses on innovation, manufacturing excellence, and strategic customer partnerships within the medical device industry. The facility includes an on-site gym that temporary staff can use, offering a convenient wellness benefit alongside a modern and well-maintained workspace.
Job Type & Location
This is a Contract position based out of Brooklyn Park, MN.
Pay and Benefits
The pay range for this position is $38.00 - $45.00/hr. 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. Eligibility requirements apply to some benefits and may depend on your job
classification and length of employment. Benefits are subject to change and may be
subject to specific elections, plan, or program terms. If eligible, the benefits
available for this temporary role may include the following:

• Medical, dental & vision
• Critical Illness, Accident, and Hospital
• 401(k) Retirement Plan – Pre-tax and Roth post-tax contributions available
• Life Insurance (Voluntary Life & AD&D for the employee and dependents)
• Short and long-term disability
• Health Spending Account (HSA)
• Transportation benefits
• Employee Assistance Program
• Time Off/Leave (PTO, Vacation or Sick Leave)
Workplace Type
This is a fully onsite position in Brooklyn Park,MN.
Application Deadline
This position is anticipated to close on Sep 30, 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 [email protected] 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.