Head of Quality & Regulatory — Hybrid, 10% Bonus

ProEdge Dental Compliance Labs; Centennial (CO); Hybride; USD 140 000 - 175 000; Plein temps

Avantages offerts par ce poste

Medical, dental, and vision coverage

401k matching

Paid time off (PTO)

Résumé du poste

ProEdge Dental Compliance Labs is seeking a Head of Quality & Regulatory to own the QMS and regulatory strategy in a hybrid in-office role in Centennial, CO. You will serve as Management Representative and interface with FDA/EPA regulators, driving CAPA, complaints, MDR, and internal audits.

You’ll build a culture of prevention, partner with engineering and operations, and elevate quality to a strategic level across the organization.

Qualifications

• 8+ years in medical device quality with leadership responsibility.
• You have led CAPA, complaints, MDR and management review activities.
• You have hosted or managed FDA inspections with calm competence.

Responsabilités

• Own the QMS end-to-end and 21 CFR 820 compliance as MR.
• Lead from the floor, drive CAPA, risk management, and validation.
• Collaborate with cross-functional teams to ensure product quality.

Connaissances

Quality leadership

Regulatory knowledge

CAPA & MDR

FDA inspection experience

Outils

QMS systems

ISO 13485

Description du poste

ProEdge Dental Compliance Labs is seeking a Head of Quality & Regulatory to own the QMS and regulatory strategy in a hybrid in-office role in Centennial, CO. You will serve as Management Representative and interface with FDA/EPA regulators, driving CAPA, complaints, MDR, and internal audits.

You’ll build a culture of prevention, partner with engineering and operations, and elevate quality to a strategic level across the organization.