What are the responsibilities and job description for the Senior Quality Assurance Engineer position at Joulé?
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:
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
- Bachelor’s degree in Engineering, Life Sciences, or related field (or equivalent experience).
- 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).