Commercial Operations - Quality Lead (Medical Devices)

Location: Remote (US) or West Chester, Pennsylvania, United States; remote work is considered case by case. Approximately 25–40% travel is required.

Base pay: $63,000–$101,430 per year.

Company

Johnson & Johnson MedTech develops healthcare and orthopaedic solutions, including joint reconstruction, trauma care, spine, robotics, and digital surgery technologies.

What you will do

• Serve as the primary quality partner for the Field Sales Network and oversee compliance with quality systems, SOPs, work instructions, and regulatory requirements.
• Lead audit and inspection readiness activities, including preparation for internal audits, FDA inspections, and other compliance assessments.
• Drive investigations, corrective and preventive actions, observation management, effectiveness monitoring, and closure of quality gaps.
• Author, review, and approve SOPs, work instructions, training materials, and operational documentation across field inventory locations.
• Coordinate field actions, recalls, quarantines, and stop shipments, including inventory impact assessment and execution reporting.
• Partner with operations, supply chain, facilities, systems, and quality stakeholders to standardize processes and improve quality performance.

Requirements

• Bachelor’s degree in Engineering, Quality, Life Sciences, Supply Chain, Business, or a related field.
• At least 5 years of experience in quality, operations, regulatory, compliance, supply chain, or medical device environments.
• Experience managing CAPAs, audits, investigations, observations, or quality systems.
• Strong project management, stakeholder management, communication, and presentation skills.
• Ability to travel approximately 25–40%.

Nice to have

• Medical device, pharmaceutical, healthcare, or other regulated-industry experience.
• Knowledge of Good Documentation Practices, CAPA, complaint handling, change control, and risk management.
• Experience with EtQ, Windchill, SAP, Move Medical, Power BI, or similar quality platforms.
• ASQ, Lean, Six Sigma, or equivalent quality certification.

Culture & Benefits

• Inclusive work environment guided by the company’s Credo.
• Vacation, sick time, holidays, personal and family time, parental leave, caregiver leave, bereavement leave, volunteer leave, and military spouse time-off.
• The Orthopaedics business is planned to become a standalone company operating as DePuy Synthes, subject to legal, regulatory, and customary approvals.