Quality Systems Auditor: GDP, DHR & FDA-ISO Expert

EXALTA Group's; Marquette (MI); On-site; USD 60,000 - 85,000; Full time

Job summary

EXALTA Group in Marquette, MI, is seeking a Quality Systems Associate to ensure the accuracy, completeness, and compliance of manufacturing documentation through router auditing, GDP adherence, and QMS support. The role focuses on reviewing DHRs and production records to verify traceability and sign-offs.

You will collaborate with Manufacturing, Quality, and Engineering to resolve discrepancies, assist with audits, and contribute to continuous improvement while maintaining a safe, compliant

Qualifications

• High School Diploma or equivalent required.
• Associate Degree in Quality, Engineering Technology, Life Sciences, Manufacturing Technology, or related field preferred.
• Minimum of 2 years of experience in a regulated manufacturing, quality assurance, quality systems, or document control environment preferred.
• Experience in medical device manufacturing and familiarity with Device History Records preferred.
• Previous auditing or documentation review experience strongly preferred.

Responsibilities

• Perform detailed audits of manufacturing routers, travelers, Device History Records (DHRs), and associated production documentation to ensure completeness, accuracy, and compliance.
• Verify that all manufacturing and inspection operations have been completed and documented according to approved procedures and specifications.
• Review production records for proper signatures, dates, revision levels, material traceability, lot control, and compliance with GDP.
• Identify documentation discrepancies, missing information, and nonconformances, and coordinate timely resolution with Manufacturing, Quality, and Engineering teams.
• Ensure compliance with FDA regulations, ISO 13485 requirements, internal quality procedures, and company policies.
• Support lot release activities through completion of final router audits and production record reviews.
• Participate in investigations related to documentation errors, audit findings, and quality system issues.
• Assist with internal audits and support external regulatory and customer audits as required.
• Maintain accurate records of audit findings and quality metrics.
• Support document control activities, including controlled document reviews and revision verification.
• Monitor trends in documentation errors and provide recommendations for CAPA.

Skills

GDP familiarity

DHR knowledge

Audit proficiency

Documentation accuracy

Regulatory compliance

MS Office & eQMS

Education

High School Diploma or equivalent

Associate Degree in quality/engineering or life sciences

Tools

MS Office

eQMS

Job description

EXALTA Group in Marquette, MI, is seeking a Quality Systems Associate to ensure the accuracy, completeness, and compliance of manufacturing documentation through router auditing, GDP adherence, and QMS support. The role focuses on reviewing DHRs and production records to verify traceability and sign-offs.

You will collaborate with Manufacturing, Quality, and Engineering to resolve discrepancies, assist with audits, and contribute to continuous improvement while maintaining a safe, compliant