Sr. Manager, Investigations

Johnson & Johnson

Raynham, Massachusetts, United States of America
Base: $122,000.00 to $211,025.00; bonus/equity: el...
8-10 years progressive experience in investigations
Expertise in root cause analysis and capa processes
Strong knowledge of fda and iso medical device regulations
The Sr. Manager, Investigations provides strategic and operational leadership for investigation activities related to quality events, compliance issues, and regulatory requirements impacting DePuy Synthes products

Job Summary

  • The Sr. Manager, Investigations provides strategic and operational leadership for investigation activities related to quality events, compliance issues, and regulatory requirements impacting DePuy Synthes products.
  • This role partners cross-functionally with Quality, Regulatory Affairs, Manufacturing, R&D, and Legal to identify root causes and reduce risk to patients and the business.
  • Employees are eligible for comprehensive benefits including medical, dental, vision, life insurance, a 401(k) savings plan, and up to 480 hours of parental leave.

Matching Summary

The Sr. Manager, Investigations provides strategic and operational leadership for investigation activities related to quality events, compliance issues, and regulatory requirements impacting DePuy Synthes products.

Salary

Base: $122,000.00 to $211,025.00; Bonus/Equity: Eligible for long-term incentive program; Benefits: Medical, dental, vision, 401(k), paid time off

Skills & Requirements

Must-have

  • 8-10 years progressive experience in investigations
  • Expertise in root cause analysis and CAPA processes
  • Strong knowledge of FDA and ISO medical device regulations
  • Proven people-leadership and team development skills
  • Ability to lead complex issue resolution in matrixed environment

Nice-to-have

  • Experience supporting regulatory inspections and audits
  • Background in orthopedic or implantable medical devices
  • Experience with electronic quality management systems (eQMS)
  • Six Sigma or Six Sigma equivalent quality certifications
  • ASQ certification or equivalent quality credentials

Key Requirements

  • Bachelor's degree required, Master's or PhD preferred
  • 8-10 years of progressive experience in regulated industry investigations
  • English proficiency required
  • Up to 15-20% domestic and/or international travel

Work Rights

Not specified

Tailored Resume

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