Preclinical QA Engineer II — Audits & CAPA

TALENT Software Services; Arden Hills (MN); On-site; USD 85,000 - 110,000; Full time

Job summary

TALENT Software Services seeks a Lab Quality Engineer II to provide quality support for preclinical laboratories, suppliers and studies worldwide, ensuring compliance with ISO 13485, 21 CFR 820, 21 CFR 58, ISO 10993 and ISO/IEC 17025. The role drives CAPA, inspection readiness and continuous quality improvement across global teams.

Responsibilities include conducting audits, collaborating with quality and lab management on process improvements, and coordinating vendor audits to maintain

Qualifications

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

Responsibilities

• Support quality systems to maintain compliance with applicable regulations and standards.
• Conduct internal and external quality audits of laboratories, procedures and controls.
• Plan, schedule and conduct vendor audits and verify supplier quality.
• Prepare for regulatory inspections and ensure inspection readiness.
• Write and publish audit and quality review reports and drive CAPA closures.
• Support or lead quality projects and maintain appropriate records.

Skills

Quality systems knowledge

Regulatory compliance

Verbal & written communication

Technical experience

Education

Bachelor's degree in chemistry or related life sciences

Job description

TALENT Software Services seeks a Lab Quality Engineer II to provide quality support for preclinical laboratories, suppliers and studies worldwide, ensuring compliance with ISO 13485, 21 CFR 820, 21 CFR 58, ISO 10993 and ISO/IEC 17025. The role drives CAPA, inspection readiness and continuous quality improvement across global teams.

Responsibilities include conducting audits, collaborating with quality and lab management on process improvements, and coordinating vendor audits to maintain