Quality Leader - Medical Devices (NPI & Compliance)

Blue Signal Search; Brooksville (FL); Vor Ort; USD 80.000 - 110.000; Vollzeit

Zusammenfassung

A leading innovator in precision electromechanical systems is seeking a Quality Manager to elevate product quality and operational excellence across its design and manufacturing teams in Brooksville, FL. The role involves driving quality assurance, developing key documentation, and training cross-functional teams in regulatory standards. Ideal candidates will have proven experience in Quality Assurance within regulated manufacturing and skills in statistical process control. This position offers the opportunity to shape a proactive quality culture.

Qualifikationen

• Proven experience in Quality Assurance or Quality Engineering within regulated manufacturing.
• Strong command of ISO 13485, ISO 9001, and FDA 21 CFR 820 standards.
• Proficiency in statistical process control and process validation methodologies.
• Exceptional communication skills and ability to lead cross-functional initiatives.

Aufgaben

• Drive quality assurance for New Product Introductions collaborating with engineering teams.
• Lead development of quality documentation like PFMEAs and Control Plans.
• Oversee process verification and first article inspections.
• Analyze manufacturing data for corrective actions and continuous improvement.
• Train cross-functional teams in regulatory standards and quality systems.

Jobbeschreibung

A leading innovator in precision electromechanical systems is seeking a Quality Manager to elevate product quality and operational excellence across its design and manufacturing teams in Brooksville, FL. The role involves driving quality assurance, developing key documentation, and training cross-functional teams in regulatory standards. Ideal candidates will have proven experience in Quality Assurance within regulated manufacturing and skills in statistical process control. This position offers the opportunity to shape a proactive quality culture.