Quality Systems Auditor

EXALTA; Marquette (MI); On-site; USD 28,000 - 39,000; Full time

Job summary

EXALTA is seeking a Quality Systems Associate to ensure the accuracy and compliance of manufacturing documentation through router audits and DHR reviews in a regulated environment in Marquette, MI. The role emphasizes GDP adherence, CAPA support, and cross-functional collaboration to improve the QMS.

The candidate will review production records, verify traceability, and support audits and lot release activities while promoting a culture of quality, safety, and continuous improvement within

Qualifications

• High school diploma or equivalent required.
• Associate degree in quality, engineering tech, life sciences, or manufacturing tech preferred.
• Minimum of 2 years in a regulated manufacturing, quality assurance, quality systems, or document control environment preferred.
• Experience in medical device manufacturing and familiarity with DHRs preferred.
• Previous auditing or documentation review experience strongly preferred.

Responsibilities

• Perform detailed audits of routers, travelers, DHRs and related production docs for completeness and compliance.
• Verify manufacturing and inspection operations are completed per procedures.
• Review production records for signatures, dates, revision levels, traceability, and GDP.
• Identify discrepancies and coordinate resolution with Manufacturing, Quality, and Engineering.
• Support FDA ISO 13485 compliance and internal quality procedures.
• Assist with lot release through final router audits and production record reviews.
• Participate in investigations of documentation errors, audit findings, and quality issues.
• Support internal and external audits as required.
• Maintain records of audit findings and quality metrics.
• Monitor trends in documentation errors and suggest CAPA actions.
• Collaborate to improve documentation processes and QMS effectiveness.
• Provide training on documentation requirements and GDP.
• Support continuous improvement and safety in the workplace.

Skills

Microsoft Office

GDP understanding

DHR knowledge

Document control

Attention to detail

Quality systems

Education

High School Diploma or equivalent

Associate Degree in Quality, Engineering Technology, Life Sciences, Manufacturing Technology, or related field

Tools

eQMS (Electronic Quality Management System)

MS Office suite

Job description

EXALTA is seeking a Quality Systems Associate to ensure the accuracy and compliance of manufacturing documentation through router audits and DHR reviews in a regulated environment in Marquette, MI. The role emphasizes GDP adherence, CAPA support, and cross-functional collaboration to improve the QMS.

The candidate will review production records, verify traceability, and support audits and lot release activities while promoting a culture of quality, safety, and continuous improvement within