Remote Quality Lead, Commercial Operations (FSN)

Johnson & Johnson MedTech; United States; Hybrid; USD 63,000 - 101,000; Full time

Job summary

Johnson & Johnson MedTech seeks a Commercial Operations Quality Lead to ensure quality systems compliance across the Field Sales Network. You will drive CAPAs, audits, training, and documentation to support regulatory requirements and continuous improvement.

The role requires strong project management, regulatory knowledge, and willingness to travel 25–40%. Remote work may be considered; West Chester, PA area preferred.

Qualifications

• Bachelor's degree required in Engineering, Quality, Life Sciences, Supply Chain, or related field.
• 5+ years of experience in Quality, Operations, Regulatory, Compliance, or Medical Device environments.
• Experience managing CAPAs, audits, investigations, observations, or quality systems.
• Strong project management and stakeholder management skills.
• Excellent communication and presentation abilities.
• Ability to travel approximately 25-40%.

Responsibilities

• Quality Systems & Compliance: be primary quality representative for FSN and ensure regulatory alignment.
• Audit & Inspection Readiness: lead audits and prepare readiness materials.
• CAPA & Observation Management: drive investigations, CAPAs, and corrective actions.
• Process Development & Documentation: author and maintain SOPs and procedures.
• Field Actions, Recalls & Stop Shipments: coordinate actions and reporting across FSN.
• Training & Quality Culture: develop training and promote continuous improvement.
• Cross-Functional Partnership: collaborate with leadership across functions.

Skills

5+ years experience

Project management

Excellent communication

Travel ability

Education

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

Tools

EtQ

Windchill

SAP

Move Medical

Power BI

Job description

Johnson & Johnson MedTech seeks a Commercial Operations Quality Lead to ensure quality systems compliance across the Field Sales Network. You will drive CAPAs, audits, training, and documentation to support regulatory requirements and continuous improvement.

The role requires strong project management, regulatory knowledge, and willingness to travel 25–40%. Remote work may be considered; West Chester, PA area preferred.