Quality Manager(Medical Device)

ClearBridge Executive Search; Cary (NC); Vor Ort; USD 110.000 - 160.000; Vollzeit

Zusammenfassung

ClearBridge Executive Search seeks an experienced Quality Manager for the medical device sector to lead QA, QMS, and regulatory compliance.

You will drive CAPA, audits, supplier quality, and continuous improvement while partnering with engineering, manufacturing, and regulatory teams.

The role requires 7–10 years in QA for medical devices, FDA/regulatory knowledge, and strong leadership.

Qualifikationen

• 7–10 years of quality assurance experience, preferably in the medical device industry.
• Strong knowledge of FDA 21 CFR Parts 820, 11, and 58.
• Experience with ISO 13485, ISO 9001, ISO 14971, and ISO 14155.
• Strong background in QMS, CAPA, audits, regulatory compliance, and continuous improvement.
• Experience managing quality teams and working with cross-functional departments.

Aufgaben

• Manage daily quality assurance activities and ensure regulatory compliance.
• Develop, implement, and maintain quality management systems (QMS).
• Ensure compliance with FDA regulations and ISO standards.
• Lead internal, external, supplier, and regulatory audits.
• Manage CAPA, investigations, corrective actions, and quality improvements.
• Oversee supplier quality and vendor compliance.
• Maintain quality documentation, procedures, and training programs.
• Monitor quality performance and identify opportunities for improvement.
• Work closely with engineering, manufacturing, and regulatory teams to resolve quality issues.
• Support regulatory inspections and maintain audit readiness.
• Lead and develop quality team members.

Kenntnisse

Quality assurance

FDA regulations

ISO standards

Audits

CAPA

Continuous improvement

Regulatory compliance

Leadership

Communication

Problem-solving

Ausbildung

Bachelor's degree in Science or related field

Tools

MasterControl

Jobbeschreibung

We are seeking an experienced Quality Manager with a strong background in the medical device industry. The ideal candidate will have experience in quality assurance, FDA regulations, ISO standards, quality management systems, audits, CAPA, and continuous improvement.

Key Responsibilities

• Manage daily quality assurance activities and ensure compliance with regulatory requirements.
• Develop, implement, and maintain quality management systems (QMS).
• Ensure compliance with FDA regulations and ISO standards.
• Lead internal, external, supplier, and regulatory audits.
• Manage CAPA, investigations, corrective actions, and quality improvements.
• Oversee supplier quality and vendor compliance.
• Maintain quality documentation, procedures, and training programs.
• Monitor quality performance and identify opportunities for improvement.
• Work closely with engineering, manufacturing, and regulatory teams to resolve quality issues.
• Support regulatory inspections and maintain audit readiness.
• Lead and develop quality team members.

Qualifications

• Bachelor's degree in Science or a related field.
• 7–10 years of quality assurance experience, preferably in the medical device industry.
• Strong knowledge of FDA 21 CFR Parts 820, 11, and 58.
• Experience with ISO 13485, ISO 9001, ISO 14971, and ISO 14155.
• Strong background in QMS, CAPA, audits, regulatory compliance, and continuous improvement.
• Experience managing quality teams and working with cross-functional departments.
• Strong communication, leadership, and problem-solving skills.
• Experience with FDA inspections and notified body audits.
• Knowledge of MasterControl or similar quality management systems.
• Experience with supplier quality and regulatory compliance.