Quality Leader, Medical Device Manufacturing & QMS

Caerus Corporation; Blaine (MN); On-site; USD 105,000 - 140,000; Full time

Job summary

Caerus Corporation in Blaine, Minnesota, seeks a Quality Manager to lead Quality Systems and Operations in a medical-device manufacturing setting, ensuring QMS execution, regulatory compliance, and continuous improvement.

You will work closely with Manufacturing, Engineering and Leadership to resolve issues, drive CAPA, audits, supplier quality, and data-driven quality decisions, influencing across functions.

Qualifications

• Bachelor’s degree in Engineering, Quality, Life Sciences or related field, or equivalent Quality experience.
• 5+ years of progressive Quality experience in medical-device manufacturing or FDA-regulated setting.
• Working knowledge of ISO 13485 and FDA medical-device QSR requirements.
• Hands-on experience with nonconformance, CAPA, root-cause analysis and corrective action.
• Experience participating in external audits or regulatory inspections.
• Experience managing direct reports or leading a Quality team.
• Cross-functional collaboration with Manufacturing, Engineering and Operations.
• Ability to analyze Quality data and identify trends.
• Proficient with Microsoft Excel and quality data communication.
• Strong written and verbal communication to influence across organization.

Responsibilities

• Provide leadership of the Quality organization, ensuring accountability and results.
• Oversee the Quality Management System (QMS) ensuring ISO 13485 and FDA compliance.
• Maintain audit readiness and lead audits and corrective actions.
• Oversee CAPA, complaints, nonconformances and investigations.
• Address production quality issues with Manufacturing and Engineering.
• Oversee nonconforming material disposition with risk assessments.
• Analyze quality data to identify trends and drive improvements.
• Establish quality performance metrics and reporting.
• Oversee supplier quality oversight and corrective actions.
• Provide quality controls for process changes, validations and new products.
• Lead coaching and development of Quality staff.
• Support staffing and organizational development.

Skills

Quality leadership

CAPA

Root cause analysis

Regulatory compliance

Cross-functional collaboration

Data analysis

Quality metrics

Documentation & reporting

Audits & inspections

Communication

Education

Bachelor’s degree

Tools

Microsoft Excel

QMS software

Quality data analysis tools

Job description

Caerus Corporation in Blaine, Minnesota, seeks a Quality Manager to lead Quality Systems and Operations in a medical-device manufacturing setting, ensuring QMS execution, regulatory compliance, and continuous improvement.

You will work closely with Manufacturing, Engineering and Leadership to resolve issues, drive CAPA, audits, supplier quality, and data-driven quality decisions, influencing across functions.