Sr. Manager, Investigations
About The Position
Johnson & Johnson announced plans to separate our Orthopaedics business to establish a standalone orthopaedics company, operating as DePuy Synthes. The process of the planned separation is anticipated to be completed within 18 to 24 months, subject to legal requirements, including consultation with works councils and other employee representative bodies, as may be required, regulatory approvals and other customary conditions and approvals. Should you accept this position, it is anticipated that, following conclusion of the transaction, you would be an employee of DePuy Synthes and your employment would be governed by DePuy Synthes employment processes, programs, policies, and benefit plans. In that case, details of any planned changes would be provided to you by DePuy Synthes at an appropriate time and subject to any necessary consultation processes. Job Overview 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 required, 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 required.
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
- Vacation –120 hours per calendar year
- Sick time - 40 hours per calendar year; for employees who reside in the State of Colorado –48 hours per calendar year; for employees who reside in the State of Washington –56 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 year
- Parental Leave – 480 hours within one year of the birth/adoption/foster care of a child
- Bereavement Leave – 240 hours for an immediate family member: 40 hours for an extended family member per calendar year
- Caregiver Leave – 80 hours in a 52-week rolling period
- Volunteer Leave – 32 hours per calendar year
- Military Spouse Time-Off – 80 hours per calendar year
- Consolidated retirement plan (pension)
- Savings plan (401(k))
- Long-term incentive program
Stand Out From the Crowd
Upload your resume and get instant feedback on how well it matches this job.
What This Job Offers
Job Type
Full-time
Career Level
Manager
