Quality Engineer

Quality Engineer

The Quality Engineer will play a crucial role in supporting the Program Management team by assisting Program Managers with validation activities, feasibility reviews, and quality issues that arise. This position involves working on programs in the development stage, focusing on pre-production quality activities for medical device, automotive, and consumer/industrial programs. Responsibilities extend from project inception to addressing customer complaints post-launch, particularly in the field of injection molded plastics.

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, ensuring quality requirements are integrated 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, supporting 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:

• Minimum of 3 years of experience in Quality Engineering.
• Experience with injection molding.
• Proficient in measuring plastics parts and conducting feasibility reviews of prints.
• Experience with validation processes, preferably in medical devices, including IQ, PQ, OQ.

Additional Skills & Qualifications:

• Experience with IQ, PQ, OQ processes.
• Medical Device Validation experience.

Work Environment:

The position supports two plants, both well-organized, temperature-controlled, and clean. The role offers flexibility in working hours from 7am-4pm or 8am-5pm, with occasional evening conference calls to accommodate overseas customers. The Quality Engineer will report to the Director of Program Development and collaborate closely with other Quality Engineers at both plants. This role offers exposure to diverse areas such as Medical Device, Automotive, and Consumer Industrial sectors, along with potential growth into Program Management.

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 24, 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 for other accommodation options.