Sr. Product Assurance Quality Engineer

Job Title: Product Assurance Quality Engineer Job Description We are seeking a dedicated Product Assurance Quality Engineer to lead and support product assurance activities in a commercial production environment. This role is essential in ensuring that all product requirements are met, facilitating seamless collaboration between Design Assurance, Manufacturing, and Supply Chain teams. Responsibilities

- Lead the development and ongoing updates of process Failure Mode and Effects Analysis (PFMEA).
- Develop and implement product inspection strategies and plans, focusing on purchased-product requirements and measurement methodologies.
- Support supplier evaluation, auditing, and performance monitoring.
- Assist in the development of in-process and final product testing protocols.
- Collaborate with Design Assurance on risk-management activities and review design documentation, including product design requirements and design verification test protocols.
- Ensure procedures, practices, and documentation comply with applicable standards and regulations in collaboration with Design Assurance and Manufacturing Engineering.
- Facilitate the transfer of specifications and processes into production during the design transfer phase.
- Support equipment control and process validations.
- Review Device History Records (DHRs) and oversee product release.
- Lead nonconforming material review and documentation processes.
- Utilize statistical methods to support inspection, testing, and process-validation activities.
- Conduct product complaint analysis, including associated risk-management file reviews and updates.
- Act as a subject-matter expert during audits and inspections, focusing on product inspection, PFMEA, nonconforming material, and product complaint analysis.
- Develop, modify, and maintain quality-system procedures, work instructions, and forms.
- Support both internal and external audit activities.
- Lead CAPA investigations, action planning, and follow-up for assigned CAPAs.

Essential Skills

- Proficiency in design control, risk management, validation, and design assurance.
- Experience in new product development, quality assurance, and mechanical process development.
- Strong knowledge in quality engineering and medical device industry standards.
- Familiarity with ISO standards and CAPA processes.

Additional Skills & Qualifications

- Bachelor's degree with at least 5 years of relevant medical-device experience, or an advanced degree with at least 3 years of relevant experience.

Work Environment This position offers a dynamic work environment within a newly updated facility featuring forward-thinking technology. The role includes the flexibility of working three days in the office and two days from home, if needed. You will join a team of two other engineers and two document control specialists, contributing to the development of innovative histography devices designed to destroy cancer cells. With strong financial backing and a stable company foundation, there are opportunities to develop a diverse skill set in a smaller company setting.
Job Type & Location
This is a Contract to Hire position based out of Plymouth, MN.
Pay and Benefits
The pay range for this position is $53.00 - $60.00/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)
Job Type & Location
This is a Contract to Hire position based out of Plymouth, MN.
Application Deadline
This position is anticipated to close on Nov 24, 2026.
Workplace Type
This is a hybrid position in Plymouth,MN. 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.