Sr. Manager, Investigations
About The Position
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 and operations. This role is accountable for ensuring investigations are thorough, timely, compliant, and consistently executed across the organization. The position partners closely with Quality, Regulatory Affairs, Manufacturing, R&D, Legal, and Compliance to identify root causes, define corrective and preventive actions, and reduce risk to patients, customers, and the business. This is a highly visible role with direct impact on product quality, regulatory compliance, and continuous improvement.
Requirements
- Bachelor’s degree, preferably in Engineering, Life Sciences, Quality, or a related technical field.
- Typically requires 8–10 years of progressive experience in investigations, quality, compliance, or related roles within a regulated industry.
- Demonstrated expertise in investigation methodologies, root cause analysis, and CAPA processes.
- Strong knowledge of medical device regulations and quality system requirements (e.g., FDA, ISO).
- Proven people-leadership experience, including coaching, performance management, and team development.
- Ability to lead complex issue resolution and influence senior stakeholders in a matrixed environment.
- English proficiency.
Nice To Haves
- Advanced degree (Master’s or PhD) preferred.
- Supporting regulatory inspections, audits, or health authority inquiries.
- Background in orthopedic or implantable medical device manufacturing.
- Experience using electronic quality management systems (eQMS).
- Experience leading global or multi-site investigation teams.
- Training or certification in root cause analysis or quality methodologies (e.g., Six Sigma).
- Strong analytical, communication, and decision-making skills.
- ASQ, Six Sigma, or equivalent quality certifications.
Responsibilities
- Lead and oversee investigation activities related to quality events, nonconformances, complaints, deviations, and compliance issues.
- Ensure investigations are conducted in accordance with internal procedures, regulatory requirements, and global quality system standards.
- Drive consistent root cause analysis and corrective and preventive action (CAPA) development and effectiveness.
- Partner cross-functionally with Manufacturing, Quality, Regulatory Affairs, R&D, and Legal to assess risk and resolve complex issues.
- Establish and maintain investigation governance, metrics, and reporting to monitor performance, trends, and compliance.
- Support regulatory inspections, audits, and health authority interactions by providing investigation expertise and documentation.
- Identify systemic issues and lead continuous improvement initiatives to reduce recurrence and improve investigation quality.
- Lead, coach, and develop investigation teams or subject-matter experts, fostering accountability and high performance.
- Embed Johnson & Johnson’s Credo and Leadership Imperatives into decision-making, people leadership, and issue resolution.
Benefits
- medical
- dental
- vision
- life insurance
- short- and long-term disability
- business accident insurance
- group legal insurance
- consolidated retirement plan (pension)
- savings plan (401(k))
- long-term incentive program
- Vacation –120 hours per calendar year
- Sick time - 40 hours per calendar year
- Holiday pay, including Floating Holidays –13 days per calendar year
- Work, Personal and Family Time - up to 40 hours per calendar
- Parental Leave – 480 hours within one year of the birth/adoption/foster care of a child.
- Condolence Leave – 30 days for an immediate family member: 5 days for an extended family member
- Caregiver Leave – 10 days
- Volunteer Leave – 4 days
- Military Spouse Time-Off – 80 hours
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What This Job Offers
Job Type
Full-time
Career Level
Manager
