Overview
Senior Quality Assurance Engineer Onsite Jobs in Portage, Michigan, USA at Ledgent Technology
Senior
Quality Assurance
Engineer Onsite
Be among the first 25 applicants. This range is provided by Ledgent Technology. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more.
Base pay range
$56.66/hr – $66.66/hr
Description
Implement quality standards, ensure compliance at every stage of the process, assess potential risks, and provide recommendations. Take responsibility for all quality control aspects including laboratories studies, clinical research, testing, operations, raw materials, production, and finished products or services. Facilitate audits and regulatory inspections, and coordinate quality trainings. This role requires independent judgment, professional expertise, and typically a degree or extensive practical experience in the field.
Job
Details
Summary: Contractor – Senior Quality Assurance Engineer
Support post-market surveillance, complaint handling, and continuous improvement activities to ensure regulatory compliance. Support activities related to the integration of a newly acquired software technology company with existing medical device quality systems, with a preference for experience in software products and non-medical devices.
Key Responsibilities
Complaint Management: Manage customer complaints, warranty claims, and field failures; analyze root causes; drive corrective actions; develop trend reports.
Quality System Management: Maintain and improve the Quality Management System (QMS) aligned with standards like ISO 9001, ISO 27001, TL 9000; create and update procedures and work instructions; collaborate on process maps for procedures.
Qualifications
Bachelor’s degree in Engineering, Life Sciences, or related field (or equivalent experience).
3+ years in Quality Engineering within regulated industries.
Knowledge of ISO 13485, 21 CFR Part 820; experience with complaint handling, CAPA, nonconformance management.
Strong problem-solving, data analysis, and communication skills.
All qualified applicants will receive consideration without regard to various protected statuses. Background checks may be required for certain positions.
Additional Details
Seniority level:
Mid-Senior level
Employment type:
Full-time
Industry: Medical Equipment Manufacturing
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Title: Senior Quality Assurance Engineer Onsite
Company: Ledgent Technology
Location: Portage, Michigan, USA
Category: Quality Assurance – QA/QC (QA Specialist / Manager, Quality Engineering, Quality Control / Manager)
