Job Title: Quality Assurance Engineer
Job Description
We are seeking a dedicated Quality Assurance Engineer to join our integration team. This role is pivotal in post-market surveillance, complaint handling, and enhancing quality systems, particularly as we integrate a newly acquired software company into our existing medical device quality system. The ideal candidate will possess experience with software products and non-medical devices, coupled with a robust background in quality systems.
Responsibilities
Investigate customer complaints, warranty claims, and field failures.
Identify root causes and drive corrective actions.
Improve the product return and complaint handling process.
Ensure timely resolution of complaints by collaborating with teams.
Provide regular trend reports to highlight recurring issues.
Maintain and improve the Quality Management System (QMS).
Align with standards such as ISO 9001, ISO, and TL 9000.
Write and update quality procedures and work instructions.
Collaborate with stakeholders to create process maps for new procedures.
Essential Skills
Additional Skills & Qualifications
Bachelor's degree in Engineering, Life Sciences, or related field (or equivalent experience).
3+ years in Quality Engineering within a regulated industry (medical devices, pharma, etc.).
Strong knowledge of ISO and 21 CFR Part 820.
Experience with complaint handling, CAPA, and nonconformance processes.
Excellent problem-solving, data analysis, and communication skills.
Work Environment
The position involves working in a dynamic and fast-paced environment where adherence to quality standards is paramount. The role requires collaboration with various teams to ensure the integration of software products into the medical device quality system is seamless and effective. The work environment encourages proactive problem-solving and innovation in quality improvements.
Pay and Benefits
The pay range for this position is $50.00 - $65.00/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 Portage,MI.
Application Deadline
This position is anticipated to close on Jun 20, 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 [email protected] (%[email protected]) for other accommodation options.
