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
QA Director – Commercial and Affiliate at Abbott | JobVerse