Sr. Product Assurance Quality Engineer

Actalent; United States; Hybrid; USD 73,000 - 83,000; Full time

Benefits offered by this job

Medical, dental & vision

401(k) Retirement Plan

Life Insurance

Disability coverage

Health Spending Account (HSA)

Transportation benefits

Employee Assistance Program

PTO

Job summary

Actalent in Plymouth, MN is seeking a Design Assurance Engineer to lead PFMEA, inspection planning, and CAPA investigations. The role collaborates with Design Assurance, Manufacturing, and Supply Chain to ensure design transfer and regulatory compliance for medical devices.

The position is a Contract to Hire with a small team of 4 engineers and 2 document control specialists, offering hybrid work (3 days in office, 2 days remote) and a competitive $53–$60/hr pay range with benefits eligibility.

Qualifications

• Requires bachelor's degree or higher with relevant medical-device experience.
• Experience with CAPA, ISO standards, and design validation.
• Proven track record in product quality assurance and process development.

Responsibilities

• Lead PFMEA development and updates.
• Develop product inspection strategies and measurement methodologies.
• Support supplier evaluation, auditing, and performance monitoring.
• Assist in in-process and final product testing.
• Collaborate on risk-management activities and review design documentation.
• Ensure procedures meet applicable medical-device standards with Manufacturing.
• Lead CAPA investigations and follow-up actions.
• Review DHRs and support product release.
• Support audits and process validations.

Skills

Design control

Risk management

Validation

New product development

Quality engineering

Education

Bachelor's degree in a relevant field

Advanced degree in medical-device field

Job description

Job Title: Design Assurance Engineer

Job Description

The Design Assurance Engineer, also known as the Product Assurance Engineer (Quality Engineer), is responsible for leading product assurance activities that support commercial production. This includes tasks such as inspection, product release, handling nonconforming materials, and analyzing product complaints. The role requires collaboration with Design Assurance on risk management updates and the transfer of design documentation into production, while ensuring product requirements are met in conjunction with Manufacturing and Supply Chain.

Responsibilities

• Lead process Failure Mode and Effects Analysis (PFMEA) development and ongoing updates.
• Develop and plan product inspection strategies, including requirements for purchased products and measurement methodologies.
• Support supplier evaluation, auditing, and performance monitoring.
• Assist in the development of in-process and final product testing.
• 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.
• Support the transfer of specifications and processes into production during design transfer.
• Facilitate equipment control and process validations.
• Review Device History Records (DHRs) and complete product release.
• Lead nonconforming material review and documentation.
• Utilize statistical methods to support inspection, testing, and process-validation activities.
• Conduct product complaint analysis, including risk-management file reviews and updates.
• Act as a subject-matter expert during audits and inspections for product inspection, PFMEA, nonconforming material, and product complaint analysis.
• Develop, modify, and maintain quality-system procedures, work instructions, and forms.
• Support internal and external audit activities.
• Lead CAPA investigations, action planning, and follow-up for assigned CAPAs.

Essential Skills

• Experience in design control and risk management.
• Proficiency in validation and design assurance.
• Expertise in new product development and quality assurance.
• Strong knowledge in mechanical and process development.
• Proven experience in quality engineering.

Additional Skills & Qualifications

• Bachelor's degree with at least 5 years of relevant medical-device experience, or
• Advanced degree with at least 3 years of relevant medical-device experience.
• Experience with medical devices and ISO standards.
• Knowledge of CAPA, engineering, and development processes.

Work Environment

The work environment includes a newly updated facility with forward-thinking technology and financial stability, backed by investors. The role involves working with an innovative histography device that aims to destroy cancer cells, contributing to the FDA approval process. You will be part of a small team comprising 2 other engineers and 2 document control specialists, with the flexibility to work 3 days in the office and 2 days from home if needed.

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 jobclassification and length of employment. Benefits are subject to change and may besubject to specific elections, plan, or program terms. If eligible, the benefitsavailable for this temporary role may include the following:

• Medical, dental & visionCritical Illness, Accident, and Hospital401(k) Retirement Plan Pre-tax and Roth post-tax contributions availableLife Insurance (Voluntary Life & AD&D for the employee and dependents)Short and long-term disabilityHealth Spending Account (HSA)Transportation benefitsEmployee Assistance ProgramTime 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 13, 2026.

Workplace Type

This is a hybrid position in Plymouth,MN.

About Actalent

The company is an equal opportunity employer and will consider all applications withoutregard to race, sex, age, color, religion, national origin, veteran status, disability,sexual orientation, gender identity, genetic information or any characteristic protectedby law.

If you would like to request a reasonable accommodation, such as the modification oradjustment 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 thecity and county of San Francisco, we will consider for employment qualified applicantswith arrest and conviction records.

Massachusetts Lie Detector:

It is unlawful in Massachusetts to require or administer a lie detector test as acondition of employment or continued employment. An employer who violates this lawshall 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 applicationsand qualifications, but final decisions are made by our hiring team. By applying, youacknowledge and agree that your application may be reviewed using AI tools.