QA Director – Commercial and Affiliate

Role Overview

• Develop, establish and maintain operational quality assurance programs, policies, processes, procedures and controls.
• Define and communicate overall vision and cascaded objectives for the departments.
• Provides overall leadership for Quality policies, approaches, and standard practices.
• Maintains alignment with US and International regulations and standards, as well as Abbott quality systems.
• Responsible for AV Quality Commercial Excellence PMO, globally.
• Oversight of quality practices for the commercial organization.
• Development, implementation and maintenance of systems around commercial distribution of Vascular products.
• Proactive approach ensuring all regulatory requirements and company QA policies and procedures are met.
• Active participation on the CAPA Review Board for internal Exception Reports, Corrective Actions and Investigations.
• Key role in external inspections/audits that take place across commercial affiliates or Corporate Audit.
• Support development and implementation of any required corrective action plans resulting from affiliate audits.
• Providing high level direction of all activities related to calibration of measurement equipment used throughout the organization.
• Assures Quality provides technical support and services to Operations and Research & Development functions.
• Identify opportunities to proactively assure compliance to all applicable internal, domestic and international quality regulations.
• Champion of Quality, Lean and disciplined problem solving throughout the organization.
• Provide influential leadership with US and OUS sites to drive proactive quality improvements and harmonization.
• Provide diligent and fact-based communication to Executive Management team, peers, and team.
• Provide management and development of the Quality staff.
• Be an effective member of the cross-functional Director organization to maintain effective Quality Metrics and define and execute activities to resolve decreases in performance.
• Support all Divisional initiatives as identified by management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements.

Requirements

• Bachelor’s degree + 16 years experience
• Minimum 10 years in quality desired with at least 3+ years management of demonstrated compliance excellence, value improvement, risk reduction, and cost containment
• Demonstrated ability to understand/ familiarity with applicable FDA and TUV regulations, and other relevant clinical/regulatory requirements.
• Class III or II medical device background in a Quality Leadership role.
• Quality System Regulations knowledge (ISO 9001, ISO 13485).
• Strong leadership skills with demonstrated ability to create momentum and deliver excellent results.
• Strong organization, speaking skills, and influential management ability.
• Ability to work in a highly matrixed and geographically diverse business environment.
• Ability to set goals and provide positive and constructive feedback respectfully to build positive relationships and improve business results.
• Ability to work effectively within a team in a fast-paced changing environment.
• Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization.
• Multi-tasks, prioritizes and meets deadlines in timely manner.
• Strong organizational, planning, and follow-up skills and ability to hold others accountable.

Benefits

• Participants who complete a short wellness assessment qualify for FREE coverage in our HIP PPO medical plan.
• Free coverage applies in the next calendar year.
• Learn more about our health and wellness benefits, which provide the security to help you and your family live full lives: www.abbottbenefits.com