Compliance Specialist IV

Johnson & Johnson•Brunswick, OH

2d•Hybrid

About The Position

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.

Requirements

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

Responsibilities

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.

Benefits

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 (may vary by state)
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
Medical
Dental
Vision