Senior Quality & Compliance Specialist

Antler; New Brunswick (NJ); On-site; USD 134,000 - 148,000; Full time

Benefits offered by this job

Vacation

Sick time

Holiday pay

Parental Leave

Bereavement Leave

Caregiver Leave

Volunteer Leave

Military Spouse Time-Off

Medical, dental, vision benefits

401(k) retirement plan

Job summary

Johnson & Johnson Health Care Systems Inc. is seeking a Compliance Specialist IV to develop and oversee Quality and Compliance programs for Med Tech US field inventory across the NA Region.

The role involves coordinating with Quality, Distribution, Sales, Commercial, and Supply Chain teams to resolve quality issues and drive improvements in field inventory and loaner programs. The position requires leading audits and investigations, ensuring regulatory compliance (FDA/ISO-13485), and developing

Qualifications

• 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.

Responsibilities

• Develop, execute, and oversee Quality and Compliance (Q&C) programs for Med Tech US field inventory within the North America Region.
• Support last mile delivery of surgical loaner sets to joint reconstruction and orthopedic customers across the US.
• Liaise with Quality, Distribution, Sales, Commercial, and Supply Chain partners on distribution quality issues.
• Identify and implement improvement opportunities aligned with business objectives and Enterprise Quality Standards.
• Define, implement, and validate quality requirements and systems in line with departmental strategies.
• Lead audits, inspections, investigations, and remediation activities.
• Ensure the Quality program maintains regulatory compliance.
• Develop, implement, and review standard operating procedures.
• Establish relationships with NA DELIVER, DePuy Synthes Sales Inc., and other Med Tech Franchise customers.
• Execute and improve systems in inspection readiness; quality programs; process changes; validation and maintenance systems; and nonconformance actions.

Skills

Lean management

Quality Assurance

Audit management

Validation and compliance

SOPs development

Process improvement

Quality oversight

FDA regulations

ISO-13485

Telecommute

Domestic travel

Education

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

Job description

Johnson & Johnson Health Care Systems Inc. is seeking a Compliance Specialist IV to develop and oversee Quality and Compliance programs for Med Tech US field inventory across the NA Region.

The role involves coordinating with Quality, Distribution, Sales, Commercial, and Supply Chain teams to resolve quality issues and drive improvements in field inventory and loaner programs. The position requires leading audits and investigations, ensuring regulatory compliance (FDA/ISO-13485), and developing