Senior RDQA Lead, Medical Devices & Quality

PowerToFly; New Jersey; On-site; USD 150,000 - 190,000; Full time

Benefits offered by this job

Health insurance

401(k)

Paid time off

Job summary

AbbVie in New Jersey seeks a Senior Manager, R&D Device Quality to guide design control, risk management and usability activities for medical devices and combination products. You will lead cross-functional teams to ensure compliance with FDA 21 CFR Part 820, ISO 13485 and other standards.

You will oversee QC strategies, CAPA investigations, process improvements, and regulatory audits, contributing to device reliability and patient safety across development programs.

Qualifications

• Minimum 10+ years in Medical Device industry and 2+ years in project management.
• BS in Engineering or Science; MS preferred.
• Strong knowledge of Medical Device development activities and regulatory standards (FDA 21 CFR Part 820, ISO 13485).
• Experience with risk management, FMEA, DOE and other quality tools.

Responsibilities

• Provide quality system guidance across design and development and change control processes.
• Lead cross-functional teams to evaluate design documentation for quality characteristics and risk management.
• Translate design requirements into manufacturing requirements for manufacturability.
• Lead RCA investigations and CAPA; drive process improvements and reliability activities.
• Support regulatory audits and inspections as subject matter expert.

Skills

Quality systems

Design controls

Risk management

Regulatory compliance

Cross-functional collaboration

Education

BS Engineering or Science

MS preferred

Tools

FMEA

DOE

CAPA

SPC

Job description

AbbVie in New Jersey seeks a Senior Manager, R&D Device Quality to guide design control, risk management and usability activities for medical devices and combination products. You will lead cross-functional teams to ensure compliance with FDA 21 CFR Part 820, ISO 13485 and other standards.

You will oversee QC strategies, CAPA investigations, process improvements, and regulatory audits, contributing to device reliability and patient safety across development programs.