Senior QMS Leader - Quality Systems & Compliance

NBSTSA; Santa Clara (CA); Hybrid; USD 142,000 - 245,000; Full time

Job summary

Johnson & Johnson in the MedTech Quality organization seeks a Senior Manager, Quality Management Systems to lead the strategy, governance, and digital transformation of the QMS across Auris sites, based in Santa Clara, CA or Cincinnati, OH.

You will partner with quality, regulatory, R&D, supply chain and clinical teams to ensure global compliance with FDA QSR, ISO 13485, EU MDR, and implement continuous improvement, inspections readiness, and scalable quality initiatives to enable business

Qualifications

• Bachelor's degree in Engineering, Life Sciences, Quality, Regulatory Affairs, or related field.

Responsibilities

• Lead strategy and governance for the Quality Management System.
• Drive enterprise-wide QMS optimization to improve compliance and efficiency.
• Oversee inspection readiness and regulatory audits.
• Partner with cross-functional leaders to ensure regulatory compliance.

Skills

Collaboration

Leadership

Stakeholder management

Data quality

Education

Bachelor's degree

Advanced degree

Job description

Johnson & Johnson in the MedTech Quality organization seeks a Senior Manager, Quality Management Systems to lead the strategy, governance, and digital transformation of the QMS across Auris sites, based in Santa Clara, CA or Cincinnati, OH.

You will partner with quality, regulatory, R&D, supply chain and clinical teams to ensure global compliance with FDA QSR, ISO 13485, EU MDR, and implement continuous improvement, inspections readiness, and scalable quality initiatives to enable business