Strategic CAPA & Quality Systems Leader

Jobtailor; Chaska (MN); On-site; USD 90,000 - 130,000; Full time

Job summary

Jobtailor is seeking a CAPA Quality professional to lead investigations, root cause analyses, and corrective actions in a regulated medical device environment. You will coordinate recalls, advisory notices, field actions, and post-market actions while developing metrics for quality reviews.

Ideal candidates have 5–8 years in Quality Assurance/Regulatory Affairs, strong CAPA expertise, and excellent cross-functional collaboration skills.

Qualifications

• Bachelor's degree or equivalent in a technical discipline with preferred focus in quality/regulatory fields.
• 5–8+ years in Quality Assurance, Quality Systems, Regulatory Affairs, or related roles in medical devices or regulated industries.
• Experience managing CAPAs, nonconformances, recalls, and quality system processes; audits preferred.

Responsibilities

• Manage day-to-day administration of the CAPA process.
• Coordinate CAPA activities from initiation through closure.
• Lead CAPA review meetings and track action item completion.
• Coordinate investigations, root cause analyses, corrective and preventive actions, and effectiveness verification.
• Develop CAPA metrics and trend analysis reports for Quality Management Reviews.

Skills

CAPA Management

Root Cause Analysis

Quality Management System

Regulatory Compliance

Cross-functional Collaboration

Project Management

Microsoft Office

Education

Bachelor's degree in Engineering, Life Sciences, Quality, Regulatory Affairs, or related technical discipline

Tools

Quality Management Software

Microsoft Office Suite

Job description

Jobtailor is seeking a CAPA Quality professional to lead investigations, root cause analyses, and corrective actions in a regulated medical device environment. You will coordinate recalls, advisory notices, field actions, and post-market actions while developing metrics for quality reviews.

Ideal candidates have 5–8 years in Quality Assurance/Regulatory Affairs, strong CAPA expertise, and excellent cross-functional collaboration skills.