Hands-On Quality Manager – Medical Devices & QMS

Caerus Corp; Blaine (MN); On-site; USD 90,000 - 130,000; Full time

Benefits offered by this job

Health, dental, vision, basic life, AD

401(k) retirement plan with employer 0

Paid time off and holidays

Tuition Assistance Program

Employee Brace Program

Job summary

Caerus Corp in Blaine, MN is seeking a Quality Manager to lead the QMS for Class II medical devices and customer products, ensuring compliance with FDA/ISO standards and driving continuous improvement.

The role involves CAPA execution, complaint handling, audits, and risk-based decision making, with hands-on leadership across quality, operations, and engineering.

Join a collaborative team committed to quality, with comprehensive benefits and opportunities to own and shape quality processes.

Qualifications

• Bachelor’s degree in Engineering, Quality, Life Sciences, or related field.
• 5+ years of progressive quality experience in a regulated manufacturing environment (medical devices strongly preferred).
• Strong working knowledge of FDA 21 CFR Part 820 and ISO 13485 requirements.
• Direct experience leading CAPA, complaint handling, nonconformance, and audit processes.
• Ability to apply root cause analysis and risk-based thinking to complex quality issues; cross-functional collaboration.

Responsibilities

• Provide leadership and ownership of the Quality Management System (QMS) within a regulated manufacturing environment, ensuring compliance with FDA, ISO 13485, and other applicable regulatory requirements.
• Maintain organizational readiness for internal and external regulatory audits and ensure sustained compliance posture, including representation during audits and leadership of audit response and closure activities.
• Lead the development, implementation, and continuous improvement of quality systems, processes, and standards to ensure operational effectiveness and regulatory compliance. Partner with operations and engineering leadership to resolve complex production quality issues and implement sustainable corrective actions.
• Own and govern the end-to-end quality system for CAPA and complaints, including prioritization, investigation strategy, root cause analysis, corrective action effectiveness, and closure oversight. Analyze quality data, trends, and systemic issues to drive risk-based decision-making and preventive actions.
• Provide oversight of supplier quality performance, including escalation and corrective action requirements. Evaluate nonconforming material trends and determine appropriate disposition decisions based on risk and business impact.
• Provide quality oversight for new product introductions and process changes to ensure compliance and risk mitigation. Collaborate with engineering, manufacturing, and leadership teams to evaluate quality risks and drive resolution strategies.
• Lead, develop, and support quality personnel by establishing expectations, priorities, and performance standards. Ensure effective execution of quality system requirements across the team and promote accountability and capability development. Align team activities with organizational quality objectives and continuous improvement initiatives.

Skills

CAPA leadership

Root cause analysis

Risk-based thinking

Regulatory compliance

Cross-functional collaboration

Quality systems

Audits

Communication skills

Education

Bachelor’s degree in Engineering, Quality, Life Sciences, or related field

Job description

Caerus Corp in Blaine, MN is seeking a Quality Manager to lead the QMS for Class II medical devices and customer products, ensuring compliance with FDA/ISO standards and driving continuous improvement.

The role involves CAPA execution, complaint handling, audits, and risk-based decision making, with hands-on leadership across quality, operations, and engineering.

Join a collaborative team committed to quality, with comprehensive benefits and opportunities to own and shape quality processes.