Quality Systems Lead: CAPA & Internal Audits

Elucent Medical Inc.; Eden Prairie (MN); On-site; USD 85,000 - 100,000; Full time

Benefits offered by this job

401(k) with company match

Health insurance

Dental insurance

Vision insurance

Paid holidays

Paid time off

Job summary

Elucent Medical is seeking a Quality Systems Specialist II to own CAPA and internal audit programs, ensuring alignment with 21 CFR Part 820 and ISO 13485. The role collaborates across departments to maintain compliant, effective quality processes and supports regulatory submissions.

The position requires leading audits, developing procedures, and guiding corrective actions with strong written and verbal communication in a fast paced medical device environment.

Qualifications

• Bachelor's degree in engineering, life sciences, or related field; equivalent experience considered.
• Minimum 5 years medical device quality systems/ISO 13485 experience; must own at least two QMS elements (CAPA or internal audit).
• Experience leading CAPA investigations with root cause analysis and verifying corrective actions.
• Experience leading internal audits; ISO 13485 Lead Auditor or CQA preferred.
• Direct experience supporting FDA inspections or third-party audits.

Responsibilities

• Own and improve CAPA and internal audit programs.
• Lead internal audits, audits coordination, and NCR/CAPA closure.
• Prepare documents for FDA inspections and external audits.
• Develop and deliver training on quality systems elements.
• Analyze quality metrics and drive continuous improvement.

Skills

Hands-on approach

Organizational skills

Communication skills

Independent work

Education

Bachelor's degree in engineering or life sciences

5+ years medical device quality systems experience

Tools

MS Office

Adobe Acrobat

eQMS platforms

Job description

Elucent Medical is seeking a Quality Systems Specialist II to own CAPA and internal audit programs, ensuring alignment with 21 CFR Part 820 and ISO 13485. The role collaborates across departments to maintain compliant, effective quality processes and supports regulatory submissions.

The position requires leading audits, developing procedures, and guiding corrective actions with strong written and verbal communication in a fast paced medical device environment.