Quality Assurance Specialist - ISO/Regulatory Audits

Veterans Sourcing Group, LLC

Saint Paul (MN)

On-site

USD 70,000 - 100,000

Full time

27 hours ago

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Job summary

Veterans Sourcing Group, LLC is seeking a Quality Assurance professional to support laboratory compliance with ISO/IEC 17025, ISO 13485 and applicable regulations. The role involves coordinating audits, CAPA activities, and ensuring inspection readiness in a medical device or regulated setting.

The ideal candidate holds a chemistry or life sciences degree and has at least three years of technical experience, with strong communication skills to interact with cross-functional teams and external

Qualifications

Bachelor’s degree in chemistry or related life sciences discipline.
Strong knowledge of ISO/IEC 17025, ISO 13485 and/or 21 CFR 58.
Strong verbal and written communication skills, both technical and conversational.
Minimum of 3 years' experience in a technical role.

Responsibilities

Support laboratory functions to maintain compliance with applicable regulations and standards.
Collaborate with quality management and laboratory management on process improvement initiatives and audits.
Plan, schedule and conduct vendor audits.
Evaluate adequacy and compliance of systems through facility- and process-based audits.
Assist in CAPA processes and corrective actions.
Prepare for regulatory inspections (FDA or other) and support inspections.