Senior Device Quality & Compliance Lead

Allergan; Branchburg Township (NJ); On-site; USD 140,000 - 210,000; Full time

Benefits offered by this job

Comprehensive benefits

401(k) plan

Long-term incentives

Job summary

AbbVie is seeking a Senior Manager, R&D Device Quality to lead quality systems for medical device components and combination products. You will guide design control, human factors, and risk management, engaging with cross-functional teams to ensure robust development processes and regulatory compliance.

In this role you will drive design verification/validation, CAPA resolution, and participate in regulatory audits while maintaining state-of-the-art quality practices across the program.

Qualifications

• Minimum 10+ years in Medical Device industry with 2+ years in project management.
• BS in Engineering or Scientific discipline; MS preferred.
• Strong knowledge of medical device development activities and standards.
• Experience with FDA QSR/21 CFR Part 820, ISO 13485, ICH Q9, ISO 14971, EN/IEC 62366, and HE75 usability principles.

Responsibilities

• Provide quality system guidance across design and development, change control, and risk management for medical device products.
• Lead cross-functional teams on design reviews, risk assessments, verification and validation activities.
• Ensure compliance with regulatory standards and oversee CAPA investigations and resolutions.
• Support regulatory audits and inspections as SME and drive quality improvements across programs.

Skills

Medical device industry experience

Project management

Quality systems knowledge

Regulatory knowledge

Communication skills

Influencing others

Risk management (FMEA)

Education

Bachelor's degree in Engineering or Science

Master's degree preferred

Tools

FMEA

DOE

Statistical process control (SPC)

Job description

AbbVie is seeking a Senior Manager, R&D Device Quality to lead quality systems for medical device components and combination products. You will guide design control, human factors, and risk management, engaging with cross-functional teams to ensure robust development processes and regulatory compliance.

In this role you will drive design verification/validation, CAPA resolution, and participate in regulatory audits while maintaining state-of-the-art quality practices across the program.