Senior QMS Leader: Digital Quality & Compliance Excellence

Regulatory Jobs; Santa Clara (CA); Sur place; USD 142 000 - 245 000; Plein temps

Avantages offerts par ce poste

401(k) plan

Pension

Résumé du poste

Johnson & Johnson is seeking a Senior Manager, Quality Management Systems for its MedTech Quality organization in Santa Clara, CA or Cincinnati, OH. The role leads strategy, governance, and global compliance of the QMS, partnering with Quality, Compliance, R&D, and Regulatory Affairs to ensure scalable, compliant systems.

The position requires a minimum of 10 years in Quality/QA within regulated healthcare, with strong records in FDA QSR, ISO 13485, and EU MDR compliance, plus leadership across

Qualifications

• Minimum 10 years leading Quality Systems, QA, or Compliance in regulated healthcare.
• Experience leading regulatory inspections and remediation efforts.
• Strong knowledge of FDA QSR, ISO 13485, EU MDR and related standards.

Responsabilités

• Lead QMS strategy, governance, and global compliance.
• Drive inspection readiness programs and regulatory interactions.
• Oversee quality system metrics, governance, and continuous improvement.
• Promote digital transformation of quality systems and data integrity.

Connaissances

Quality Systems

Regulatory compliance

Audit readiness

Executive communication

Digital quality transformation

Formation

Bachelor's degree (Engineering/Life Sciences/Quality/Regulatory)

Outils

eQMS

Description du poste

Johnson & Johnson is seeking a Senior Manager, Quality Management Systems for its MedTech Quality organization in Santa Clara, CA or Cincinnati, OH. The role leads strategy, governance, and global compliance of the QMS, partnering with Quality, Compliance, R&D, and Regulatory Affairs to ensure scalable, compliant systems.

The position requires a minimum of 10 years in Quality/QA within regulated healthcare, with strong records in FDA QSR, ISO 13485, and EU MDR compliance, plus leadership across