Senior Quality & Compliance Specialist - Remote

Johnson & Johnson MedTech; West Chester (Chester County); Remote; USD 94,000 - 152,000; Full time

Job summary

Johnson & Johnson is recruiting a Senior Quality & Compliance Specialist to develop, execute and oversee Quality & Compliance programs for orthopedic last mile operations across the US. The role works with Quality, Supply Chain, Deliver, Sales and Commercial teams to ensure timely resolution of quality issues.

It resides in DePuy Synthes Commercial Quality Major Markets. Travel up to 25% domestically/internationally may be required.

Qualifications

• Bachelor's degree or equivalent required.
• 6–7 years of relevant regulated healthcare/quality experience.
• Experience with FDA CFR 820, ISO 13485/9001.
• Experience with quality systems, audits, CAPA, nonconformance.

Responsibilities

• Define and validate quality requirements and systems.
• Serve as single contact for operations.
• Lead audits, inspections, investigations, remediation.
• Ensure regulatory compliance of Quality program.
• Support distribution processes and new go-to-market models.
• Develop, implement, and review SOPs.
• Maintain relationships with last mile operations and customers.
• Be a change agent.

Skills

Communication

Problem-solving

Root cause analysis

Good documentation practices

Cross-functional collaboration

MS Office

Education

Bachelor's degree or equivalent

Tools

Windchill

ETQ

Summit

ERP

Warehouse Management Systems

Job description

Johnson & Johnson is recruiting a Senior Quality & Compliance Specialist to develop, execute and oversee Quality & Compliance programs for orthopedic last mile operations across the US. The role works with Quality, Supply Chain, Deliver, Sales and Commercial teams to ensure timely resolution of quality issues.

It resides in DePuy Synthes Commercial Quality Major Markets. Travel up to 25% domestically/internationally may be required.