Senior Manager, Medical Device Quality Systems

AbbVie • North Chicago, IL

413d • $117,500 - $223,500

About The Position

The Senior Manager, Medical Device Quality Systems at AbbVie is responsible for the sustainment, improvement, and globalization of the quality management system for medical devices and combination products. This role includes serving as the Deputy Person Responsible for Regulatory Compliance under EU MDR 2017/745, providing compliance expertise, leading continuous process improvement initiatives, and ensuring compliance with external regulations and standards.

Requirements

• Bachelor's degree in engineering, physical science, life science, or pharmacy.
• Minimum of 8 years of industry experience in a GXP regulated environment, with at least 3 years in Quality Assurance Operations Management.
• ISO 13485 Lead Auditor certification is required; additional certifications like ASQ CMQ-OE, Six Sigma Black Belt, or PMP are desirable.
• Quality Assurance, Quality Control, Regulatory, Manufacturing, Laboratory or Validation background in a GXP regulated environment is required.
• Thorough understanding of GXP regulations and regulatory inspection experience.
• Strong project management skills and excellent oral and written communication skills.

Nice To Haves

• Additional accreditation by a professional body such as ASQ or Six Sigma Black Belt certification.

Responsibilities

• Serve as the Deputy Person Responsible for Regulatory Compliance under EU MDR 2017/745, supporting quality management supervision.
• Host External Audits to demonstrate compliance with ISO 13485 and other country-specific device audits under MDSAP.
• Conduct Internal Audits to assess compliance of the quality management system according to ISO 13485 and other regulations.
• Lead root cause investigation and corrective action planning in response to audit observations.
• Maintain expertise in current and emerging regulations impacting medical devices and combination products.
• Perform regulatory compliance assessments to support critical business decisions.
• Analyze and interpret quality system performance metrics for Management Reviews.
• Program manage initiatives to improve and globalize the quality management system.

Benefits

• Paid time off (vacation, holidays, sick)
• Medical, dental, and vision insurance
• 401(k) plan
• Short-term incentive programs
• Long-term incentive programs

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Industry: Chemical Manufacturing
• Education Level: Bachelor's degree