Senior Quality Assurance Engineer

System One; Portage (MI); Hybrid; USD 80,000 - 110,000; Full time

Job summary

A leading company in the healthcare industry is seeking a Senior Quality Assurance Engineer to oversee complaint management and quality system management in Portage, MI. This hybrid position offers a dynamic environment with responsibilities including analyzing customer complaints and ensuring compliance with quality standards. You will play a key role in delivering quality assurance practices aligned with industry regulations, contributing to product reliability and customer satisfaction.

Benefits

Health and welfare benefits

401(k) participation

Qualifications

• 3+ years of experience in Quality Engineering in regulated industries.
• Strong knowledge of quality system regulations.
• Experience with complaint handling and nonconformance management.

Responsibilities

• Manage customer complaints and drive corrective actions.
• Support maintenance of the Quality Management System.
• Develop and deliver trend analyses and reports.

Skills

Problem-solving

Data analysis

Communication

Education

Bachelor’s degree in Engineering or Life Sciences

Job description

Job Title: Senior Quality Assurance Engineer
Location: Portage, MI - HYBRID
Hours/Schedule: Mon - Fri, 8:00 AM - 5:00 PM
Type: 12-month contract

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