Job Title: Senior Quality Assurance Engineer
Location: Portage, MI
Hours/Schedule: Mon - Fri, 8:00 AM - 5:00 PM
Type: Contract, Potential for extension or conversion to permanent
 
Responsibilities Complaint Management and Issue Resolution: Manage and analyze customer complaints, warranty claims, and field failures to identify root causes, drive effective corrective actions, and improve product reliability. Support the development and assessment of product return process as part of complaint handling. Collaborate with cross-functional teams to ensure timely closure and documentation of complaints. Develop and deliver regular trend analyses and reports to identify systemic issues and areas for improvement. Quality System Management: Support the maintenance and continuous improvement of the Quality Management System (QMS) in alignment with industry standards (e.g., ISO 9001, ISO 27001, TL 9000). Create, review, and update quality procedures, work instructions, and best practices. Consult with various Post Market stakeholders to create and propose process maps that may be used as part of procedure creation.   Requirements Bachelor’s degree in Engineering, Life Sciences, or related field (or equivalent experience). 3+ years of experience in Quality Engineering within the medical device, pharmaceutical, or related regulated industry. Strong knowledge of quality system regulations (ISO 13485, 21 CFR Part 820) Experience with complaint handling, CAPA, and nonconformance management. Excellent problem-solving, data analysis, and communication skills.

Benefits
System One offers eligible employees health and welfare benefits coverage options, including medical, dental, vision, spending accounts, life insurance, voluntary plans, and participation in a 401(k) plan.
 

Ref: #558-Scientific

System One, and its subsidiaries including Joulé, ALTA IT Services, TeamPeople, and Mountain Ltd., are leaders in delivering outsourced services and workforce solutions across North America. We help clients get work done more efficiently and economically, without compromising quality. System One not only serves as a valued partner for our clients, but we offer eligible employees health and welfare benefits coverage options including medical, dental, vision, spending accounts, life insurance, voluntary plans, as well as participation in a 401(k) plan.

System One is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, age, national origin, disability, family care or medical leave status, genetic information, veteran status, marital status, or any other characteristic protected by applicable federal, state, or local law.