Quality Director — Medical Devices (Onsite Lincoln)

Virtual Incision; Lincoln (NE); Sur place; USD 140 000 - 210 000; Plein temps

Avantages offerts par ce poste

Medical, Dental, Vision Insurance

Disability Insurance

Life Insurance

401(k)

Flexible working hours

PTO

Résumé du poste

Virtual Incision is seeking a Director of Quality to lead the Quality function, ensuring the QMS is compliant, scalable, and integrated with manufacturing and business operations. The role partners with Engineering, Manufacturing, Regulatory Affairs, Supply Chain, and Operations to maintain product quality and readiness for commercialization.

The Director will guide quality system activities, investigations, audits, and problem-solving to ensure timely resolution of quality and compliance issues

Qualifications

• Bachelor's degree in Engineering, Quality, Manufacturing, Life Sciences, or related technical discipline.
• 10+ years of progressive Quality Assurance and Quality Systems experience in regulated industry.
• 5+ years of quality leadership overseeing quality systems and team development.

Responsabilités

• Lead and maintain the Quality Management System (QMS) ensuring FDA/ISO compliance.
• Oversee CAPA, complaint handling, nonconforming material control, document control, training, and audits.
• Lead investigations, root-cause analyses, corrective and preventive actions.

Connaissances

QMS leadership

FDA/ISO knowledge

Root cause analysis

Cross-functional leadership

Problem solving

Formation

Bachelor's degree in Engineering, Quality, Manufacturing, Life Sciences, or related

Description du poste

Virtual Incision is seeking a Director of Quality to lead the Quality function, ensuring the QMS is compliant, scalable, and integrated with manufacturing and business operations. The role partners with Engineering, Manufacturing, Regulatory Affairs, Supply Chain, and Operations to maintain product quality and readiness for commercialization.

The Director will guide quality system activities, investigations, audits, and problem-solving to ensure timely resolution of quality and compliance issues