Sr. Product Assurance Quality Engineer

Actalent; Plymouth (MN); Hybride; USD 73 000 - 83 000; Plein temps

Résumé du poste

Actalent in Plymouth, MN is seeking a Design Assurance Engineer to lead product assurance activities, PFMEA development, and transfer of design into production. The role collaborates with Design Assurance, Manufacturing, and Supply Chain to ensure product requirements are met, with a focus on audits, CAPA, and process validation.

The ideal candidate has medical-device experience and strong expertise in design control, risk management, validation, and quality engineering.

Qualifications

• Design control and risk management experience required.
• Validation and design assurance experience.
• New product development and quality assurance experience.
• Experience with CAPA, audits, and regulatory expectations is a plus.

Responsabilités

• Lead PFMEA development and ongoing updates.
• Develop product inspection strategies and measurement methods.
• Support supplier evaluation, auditing, and monitoring.
• Assist in in-process and final product testing.
• Collaborate on risk-management activities and review design verification protocols.
• Ensure procedures and documentation comply with applicable standards with Design Assurance and Manufacturing Engineering.
• Lead transfer of specifications 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.
• Use statistical methods to support inspection, testing, and process validation.
• Conduct product complaint analysis and risk-management reviews.
• Act as SME during audits and inspections for product inspection, PFMEA, NMN, and complaints.
• Develop, modify, and maintain quality-system procedures and forms.
• Support internal and external audit activities.
• Lead CAPA investigations and follow-up.

Connaissances

Design controls

Risk management

Validation

New product development

Quality engineering

Formation

Bachelor's degree (medical-device)

Advanced degree (medical-device)

Description du poste

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 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)

Application Deadline

This position is anticipated to close on Nov 13, 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 [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.