Senior Device Quality Leader for Medical Devices & Combos

AbbVie Inc.; Chippewa Falls (WI); Hybrid; USD 120,000 - 160,000; Full time

Job summary

AbbVie Inc. is seeking a senior quality system professional to support medical device and combination product quality assurance. The role develops QA policies, coordinates cross-functional activities with R&D, manufacturing, supply chain, regulatory affairs, and leads training and continuous improvement initiatives.

Responsibilities include design control, regulatory compliance across ISO, CFR and EU standards, and representing AbbVie in external industry groups as needed.

Qualifications

• Bachelor’s degree in chemistry, pharmacy, biology, microbiology, engineering or related technical field.
• 8+ years of quality assurance or quality system oversight experience; device regulation knowledge preferred.
• Experience leading cross-functional teams and driving project results.
• Knowledge of ISO, US CFR and EU medical device regulations; regulatory agency interface preferred.
• Ability to assess impact of quality system changes across divisions.

Responsibilities

• Develop, implement and sustain quality policies and procedures for medical devices and combination products.
• Oversee design control with R&D, Manufacturing Science & Technology, supply chain and regulatory affairs.
• Coordinate quality system elements, training, continuous improvement, and cross-site support.
• Represent AbbVie in external industry groups when appropriate.
• Consolidate quality oversight across medical device and combination product lines.

Skills

Quality Assurance

Regulatory Knowledge

Cross-functional Leadership

Communication Skills

Education

Bachelor’s Degree in Science/Engineering

Job description

AbbVie Inc. is seeking a senior quality system professional to support medical device and combination product quality assurance. The role develops QA policies, coordinates cross-functional activities with R&D, manufacturing, supply chain, regulatory affairs, and leads training and continuous improvement initiatives.

Responsibilities include design control, regulatory compliance across ISO, CFR and EU standards, and representing AbbVie in external industry groups as needed.