Advanced Quality Engineer

Job description

Job Title: Advanced Quality EngineerJob Description
This role is pivotal in supporting the Program Management team with pre-production quality activities for medical device, automotive, and consumer/industrial programs.

The Quality Engineer will work on programs from inception to completion, ensuring high standards and addressing any customer complaints.

The focus will be on injection molded plastics, with a significant emphasis on medical devices.
Responsibilities

+ Interpret and review complex engineering drawings and specifications.

+ Support and perform medical product validation activities, including Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ), and Process Characterization (PC).

+ Ensure compliance with industry-specific standards, including IATF, ISO 9001, and medical device quality and regulatory requirements.

+ Actively participate in new product launches, integrating quality requirements into design, process, and production planning.

+ Develop, document, and maintain standard work instructions for inspection, testing, and manufacturing processes.

+ Conduct first article inspections (FAI) and evaluate results against design specifications.

+ Perform and document risk assessments, process capability studies, and tolerance stack-ups.

+ Drive Corrective and Preventive Actions (CAPA) using structured problem-solving tools (e.g., 8D, 5 Why, Fishbone).

+ Participate in internal and supplier audits, and support regulatory and customer audits.

+ Lead or assist with the development of control plans, PFMEAs, and process flow diagrams.

+ Analyze nonconformities, trends, and quality data to support continuous improvement initiatives.

Essential Skills

+ 3+ years of experience in Quality Engineering.

+ APQP experience.

+ Injection molding experience.

+ Experience measuring plastic parts.

+ Feasibility reviews of prints - print/tolerance reviews.

+ Validation experience, especially in medical devices, including IQ, OQ, and PQ.

Additional Skills & Qualifications

+ Gage R&R.

+ Experience in Medical Device Validation.

Work Environment
The work environment includes two well-organized, temperature-controlled, and clean plants.

The position offers flexible hours from 7am-4pm or 8am-5pm, with occasional evening conference calls for overseas clients.

The role involves collaboration with other Quality Engineers and reports to the Director of Program Development.
Job Type & Location
This is a Contract to Hire position based out of Vicksburg, Michigan.
Pay and Benefits
The pay range for this position is $36.06 - $43.27/hr.
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 Vicksburg,MI.
Application Deadline
This position is anticipated to close on Oct 27, 2025.
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 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.

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 due to a disability, please email actalentaccommodation@actalentservices.com (%20actalentaccommodation@actalentservices.com) for other accommodation options.

Required Skill Profession

Other General