QA Director, Commercial and Affiliate

Job Title

QA Director, Commercial and Affiliate

The QA Director, Commercial and Affiliate will develop, establish and maintain operational quality assurance programs, policies, processes, procedures and controls ensuring that the organization conforms to established standards and agency regulations. This position can work out of any AVD Vascular Division location.

• Define and communicate overall vision and cascaded objectives for the departments.
• Provide overall leadership for Quality policies, approaches, and standard practices. Maintain 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, including development, implementation and maintenance of systems around commercial distribution of Vascular products, and quality responsibilities for distributors/in-country partners and affiliates worldwide who distribute product and/or process customer complaints. Proactively ensure all regulatory requirements and company QA policies and procedures are met as part of any commercial launches and/or applicable pilot program discussions.
• Participate on the CAPA Review Board for internal Exception Reports, Corrective Actions and Investigations. Play a key role in external inspections/audits that take place across commercial affiliates or Corporate Audit. Provide support for development and implementation of any required corrective action plans resulting from affiliate audits.
• May provide high level direction of calibration activities for measurement equipment used throughout the organization in accordance with policy, including equipment traceability, out of tolerance management, and interval management.
• Provide technical support and services to Operations and Research & Development functions, supporting approved projects and objectives of both functions.
• Identify opportunities to proactively assure compliance with applicable internal, domestic and international quality regulations (e.g., US 21 CFR 820 (QSR), ISO 13485).
• Champion Quality, Lean and disciplined problem solving to add value through risk reduction, cost improvement, and budgetary responsibility.
• Provide influential leadership with US and OUS sites to drive proactive quality improvements and harmonization.
• Provide diligent and fact-based communication to Executive Management, peers, and team.
• Manage and develop the Quality staff.
• Work within a cross-functional Director organization to foster continuous quality compliance, cost, and predictive measures improvements by maintaining effective Quality Metrics and executing activities to resolve performance decreases.
• Support Divisional initiatives in Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements.
• Comply with FDA regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments. Maintain positive and cooperative communications with all levels of employees, customers, contractors, and vendors.
• Identify opportunities to proactively assure compliance to quality regulations (including EN ISO 13485, 21
  
  CFR 820, MDD, JPAL and CMDR).
• Ensure product acceptance activities comply with regulatory requirements. Report on the performance of the quality system.

• Bachelor’s degree + 16 years experience
• Minimum 10 years in quality with at least 3+ years of demonstrated compliance excellence, value improvement, risk reduction, and cost containment
• Demonstrated understanding of applicable FDA and TUV regulations and other clinical/regulatory requirements. Class III or II medical device background in a Quality Leadership role. Knowledge of Quality System Regulations (ISO 9001, ISO 13485).
• Strong leadership with the ability to create momentum and deliver results. Strong organizational, communication, and influential management skills. Ability to work in a highly matrixed and geographically diverse environment. Ability to set goals and provide positive and constructive feedback to build relationships and…