QMS Senior Manager: Quality, Compliance & Transformation

6267-Auris Health Inc. Legal Entity; Santa Clara (CA); On-site; USD 142,000 - 245,000; Full time

Benefits offered by this job

401(k) plan

Vacations 120 hours/year

Sick time 40 hours/year

Holiday pay 13 days/year

Parental Leave 480 hours/year

Bereavement Leave 240 hours/year

Job summary

Johnson & Johnson is seeking a Senior Manager, Quality Management Systems to lead the MedTech QMS in Santa Clara, CA (or Cincinnati, OH). You will drive strategic quality initiatives, ensure regulatory alignment, and prepare for FDA inspections.

The role requires a strong background in GMP/GDP, ISO 13485, EU MDR, and global quality systems, with a focus on continuous improvement and risk-based decision making.

Qualifications

• Bachelor’s degree required; advanced degree preferred.
• 10+ years in quality systems or compliance leadership in regulated healthcare.
• Experience leading regulatory inspections and audits in medical devices.
• Strong knowledge of GMP, GDP, data integrity and risk management.

Responsibilities

• Develop and align the Quality Management System with business goals and regs.
• Lead enterprise QMS optimization and cross-functional quality initiatives.
• Oversee document control, CAPA, training, and records management teams.
• Establish KPIs and drive continuous improvement and inspection readiness.
• Prepare for FDA inspections and Notified Body audits; ensure global compliance.
• Partner with leadership to identify risks and implement mitigations.

Skills

Quality mgmt systems

Regulatory compliance

FDA QSR

ISO 13485

EU MDR

MDSAP

Leadership

Audit readiness

Education

Bachelor's degree

Advanced degree preferred

Tools

eQMS

AI-enabled quality platforms

Job description

Johnson & Johnson is seeking a Senior Manager, Quality Management Systems to lead the MedTech QMS in Santa Clara, CA (or Cincinnati, OH). You will drive strategic quality initiatives, ensure regulatory alignment, and prepare for FDA inspections.

The role requires a strong background in GMP/GDP, ISO 13485, EU MDR, and global quality systems, with a focus on continuous improvement and risk-based decision making.