Sr. Manager, Investigations

6149-DePuy Synthes Products Inc. Legal Entity; Raynham (MA); On-site; USD 122,000 - 211,000; Full time

Job summary

Sr. Manager, Investigations at DePuy Synthes leads strategic and operational investigation activities related to quality events, compliance issues, and regulatory requirements impacting DePuy Synthes products.

The role partners with Quality, Regulatory Affairs, Manufacturing, R&D, Legal, and Compliance to identify root causes, define corrective actions, and reduce risk to patients, customers, and the business. It is a high-visibility position with broad cross-functional impact.

Qualifications

• Bachelor's degree required in Engineering, Life Sciences, Quality, or related field.
• 8–10 years of progressive experience in investigations, quality, compliance, or related roles.
• Strong knowledge of medical device regulations and quality system requirements (FDA, ISO).
• Proven people leadership, coaching, performance management, and team development.
• Experience leading global or multi-site investigation teams.
• Training or certification in root cause analysis or quality methodologies (e.g., Six Sigma).

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.

Skills

Investigation leadership

Root cause analysis

CAPA processes

Regulatory compliance

Medical device regulations

Stakeholder influence

People leadership

Education

Bachelor's degree (Engineering/Life Sciences)

Advanced degree preferred

Tools

eQMS

Job description

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at jnj.com As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.

Job Function: Legal & Compliance Job Sub Function: Law Business Partners Job Category: Professional All Job Posting Locations: Raynham, Massachusetts, United States of America

Job Description: 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.

Key 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.

Qualifications

Education Bachelor's degree required, preferably in Engineering, Life Sciences, Quality, or a related technical field. Advanced degree (Master's or PhD) preferred.

Experience and Skills Required

• 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.
• Preferred Experience 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.
• Other Language: English proficiency required.
• Travel: Up to 15-20% domestic and/or international travel.
• Certifications (preferred): ASQ, Six Sigma, or equivalent quality certifications.

The expected base pay range for this position is $122,000.00 to $211,025.00.

• Subject to the terms of their respective plans, employees and/or eligible dependents are eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance.
• Subject to the terms of their respective plans, employees are eligible to participate in the Company's consolidated retirement plan (pension) and savings plan (401(k)).
• This position is eligible to participate in the Company's long-term incentive program.
• Subject to the terms of their respective policies and date of hire, employees are eligible for the following time off benefits: 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
• Subject to the terms of their respective policies and date of hire, employees are eligible for the following time off 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 period10 days Volunteer Leave - 32 hours per calendar year Military Spouse Time-Off - 80 hours per calendar year
• Co-Ops and Intern Positions: Please use the following language: Co-Ops/Interns are eligible to participate in Company sponsored employee medical benefits in accordance with the terms of the plan. Co-Ops and Interns are eligible for the following sick time benefits: up to 40 hours per calendar year; for employees who reside in the State of Washington, up to 56 hours per calendar year. Co-Ops and Interns are eligible to participate in the Company's consolidated retirement plan (pension).
• Positions Represented by CBA: This position is eligible for benefits to include medical, dental, vision and time off, as well as any others as provided for in the applicable Collective Bargaining Agreement. The following link to general company benefits information MUST also be included in the posting: Please use the following language: For additional general information on Company benefits, please go to: - https://www.careers.jnj.com/employee-benefits

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com/.