Advanced Quality Engineer

Advanced Quality Engineer

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. Opportunity for growth - move into Program Manager role down the line Pre-production focused job 60-70% on the floor - 30-40% behind the desk and documentation Usually running 4 projects at a time - will adjust as needed to manage work load APQP process Creating and submitting PPAPs, customer visits, addressing corrective actions, updating work instructions, dealing with containment, writing protocols for validation, and involved in pre-production trials Would like someone who is involved with print reviews and understands metrology Will report directly to the director of program development - only QE on the PM team, they will work closely with the QEs.

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.

Must Have Qualifications 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.

Work Environment The work environment includes two well-organized, temperature-controlled, and clean plants. Flexible hours from 7am-4pm or 8am-5pm, with occasional evening conference calls for overseas clients.

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 17, 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, please email actalentaccommodation@actalentservices.com for other accommodation options.