Compliance Specialist IV

6077-Johnson & Johnson HCS Inc. Legal Entity; New Brunswick (NJ); Remote; USD 134,000 - 148,000; Full time

Benefits offered by this job

Telecommute option

Travel up to 20%

Job summary

Johnson & Johnson Health Care Systems Inc. in New Brunswick, NJ is seeking a Compliance Specialist IV to lead quality and compliance programs across US field inventory, including field inventory locations, loaner sites, and distribution centers.

The role requires a Bachelor's degree in Engineering, Life Sciences, or related field and 6 years of experience in compliance, quality leadership, audits, and regulatory requirements, with up to 20% domestic travel and telecommute possibility.

Qualifications

• Bachelor's degree required in Engineering or Life Sciences or related field.
• 6+ years of experience in compliance or as Compliance Specialist IV.
• Lean management and QA experience.
• Lead quality programs and audits; ensure regulatory compliance.
• Develop, implement, review SOPs and quality systems.

Responsibilities

• Develop, execute, and oversee Quality and Compliance programs for US field inventory in NA region.
• Support delivery of surgical loaner sets to orthopedic customers across the US.
• Collaborate with Quality, Distribution, Sales, Commercial, and Supply Chain teams on distribution quality issues.
• Identify improvement opportunities aligned with Enterprise Quality Standards.
• Lead audits, inspections, investigations, remediation, and corrective actions.

Skills

Lean management

Quality Assurance

Audit management

Validation & compliance

SOPs development

Process improvement

Education

Bachelor's degree in Engineering, Life Sciences, or related field

Job description

Job Details

Employer: Johnson & Johnson Health Care Systems Inc. Job Title: Compliance Specialist IV Job Code: A011.7404.7 Job Location: New Brunswick , NJ Job Type: Full-Time Rate of Pay: $134,000 - $148,000/year

Job Function: Quality Job Sub Function: Customer/Commercial Quality Job Category: Professional All Job Posting Locations: New Brunswick, New Jersey, United States of America

Job Duties

• Develop, execute, and oversee Quality and Compliance (Q&C) programs for Med Tech US field inventory within the North America Region, including Field Inventory Locations (FIL), Field Sales Offices, Loaner Sites, and Distribution Centers (DC).
• Support “last mile” delivery of surgical loaner sets support joint reconstruction and orthopedic customers across the US.
• Serve as a liaison with Quality, Distribution, Sales, Commercial, and Supply Chain partners on distribution quality related matters to drive timely resolution of quality related issues.
• Identify and support implementation of improvement opportunities consistent with business objectives and the Enterprise Quality Standards.
• Define, implement, and validate quality requirements and systems in alignment with departmental strategies.
• Participate in and lead audits, inspections, investigations, and remediation activities.
• Ensure the Quality program maintains regulatory compliance.
• Provide quality support for existing and new distribution processes.
• Develop, implement, and review standard operating procedures.
• Establish and maintain relationships with NA DELIVER, DePuy Synthes Sales Inc., and other Med Tech Franchise customers in order to solve problems and meet changing competitive and regulatory environments.
• Execute and improve systems/processes in Inspection readiness; Commercial Quality including field inventory consignment and Loaner programs; Process changes; Validation, Calibration, and Preventive Maintenance systems; Delivery service issue trending; and Nonconformance investigation and corrective action plan development, implementation, and effectiveness monitoring.

Requirements

Employer will accept a Bachelor's degree in Engineering, Life Sciences, or related field and 6 years of experience in the job offered or in a Compliance Specialist IV-related occupation.

1. Lean management and Quality Assurance;
2. Quality program leadership;
3. Audit management;
4. Validation and compliance;
5. Standard Operating Procedures (SOPs) development, implementation, and review;
6. Process improvement activities including value-based healthcare, Agile methodology, root cause analysis, statistical process control, and process mapping and reengineering;
7. Quality oversight of external sales agents/consignment models;
8. Health Authority or notified body;
9. FDA regulations and ISO-13485 standards.

*May telecommute. *Up to 20% domestic travel required. This job posting is anticipated to close on 9/17/2026.

Benefits

• 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; 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
• Employees are 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.
• For additional general information on Company benefits, please go to: - https://www.careers.jnj.com/employee-benefits

Required Skills

At Johnson & Johnson,we believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented, treated, and cured,where treatments are smarter and less invasive, andsolutions 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/.

Preferred Skills

At Johnson & Johnson,we believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented, treated, and cured,where treatments are smarter and less invasive, andsolutions 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/.

Equal Opportunity Employer

Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.

If you are an individual with a disability and would like to request an accommodation, please contact us via https://www.jnj.com/contact-us/careers or contact AskGS to be directed to your accommodation resource.

Additional Information

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