Quality Systems Lead - CAPA & Audits

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

Benefits offered by this job

401(k) matching

Health insurance

Dental insurance

Vision insurance

Paid Holidays

Paid Vacation Days

Paid Sick Days

Short Term Disability

Long Term Disability

Life Insurance

Pet Insurance

Employee Assistance Programs

Job summary

Elucent Medical, Inc. is seeking a Quality Systems Specialist II in Minnesota to own CAPA and internal audit programs, coordinate audits, and support regulatory submissions.

You will drive continuous improvement of the quality system, partner with cross-functional teams, and help ensure compliance with 21 CFR Part 820 and ISO 13485. The role emphasizes independence, risk assessment, and effective corrective actions, with collaboration across Quality and Regulatory Affairs.

Qualifications

• Bachelor's degree in engineering or life sciences or related field; equivalent experience considered.
• Minimum 5 years in medical device quality systems/ISO 13485 with ownership of at least two elements.
• Experience leading CAPA investigations with root cause analysis; internal audits preferred.
• ISO 13485 Lead Auditor or ASQ CQA certification preferred, FDA inspection support helpful.
• Strong technical writing and excellent communication skills.

Responsibilities

• Own and improve CAPA and internal audit programs within the quality system.
• Coordinate document packages for internal audits and FDA inspections.
• Develop and maintain quality programs, procedures, and training content.
• Lead audit planning, execution, reporting, and closure follow-up.
• Report quality metrics and trends; drive remediation and continuous improvement.
• Provide guidance to QA staff and support Regulatory Affairs for submissions.
• Ensure compliance with 21 CFR Part 820, ISO 13485, and related standards.

Skills

Hands-on

Organization

Technical writing

Regulatory knowledge

Communication

Cross-functional

Education

Bachelor's degree in engineering, life sciences, or related field

Tools

MS Office

Adobe Acrobat

eQMS platforms

Job description

Elucent Medical, Inc. is seeking a Quality Systems Specialist II in Minnesota to own CAPA and internal audit programs, coordinate audits, and support regulatory submissions.

You will drive continuous improvement of the quality system, partner with cross-functional teams, and help ensure compliance with 21 CFR Part 820 and ISO 13485. The role emphasizes independence, risk assessment, and effective corrective actions, with collaboration across Quality and Regulatory Affairs.