Qualifications Summary
Extensive experience in medical device manufacturing at all levels of the QA/RA organization in organizations of all sizes. Proven track record of improvement programs and managing departments from 2-100 persons including strategy formulation and leadership.
Areas of Expertise
Quality Management Systems and all related subsystems (new program establishment and process improvements) – Regulatory Compliance (U.S. and EU) – First- and Second-Party Audits – Mock Inspections – Remediation Strategies and Activities – Regulatory Agency Responses (e.g., nonconformances, warning letters, consent decrees, etc.) – Supplier Quality – Inspection Readiness – Process Improvement Initiatives
Core Competencies
Communication: Distills complex issues and ideas down to simple terms that others can readily grasp. Delivers professional presentations with focus and poise. Listens to hear what both is being said and not being said in order to understand the subtleties and complexity for a given matter.
Driving for Results: Displays good judgment in directing attention and efforts across competing priorities. Champions initiatives that raise the bar for effective execution. Uses rigorous analysis or external benchmarking to establish new ways of doing things that yield higher levels of performance.
Leading Innovation & Change: Ensures that individuals and teams take time to ask, “What if?,” “What else?,” and “Why not?,” even under tight timelines and stressful circumstances. Clears unnecessary constraints and obstacles that might undermine innovative action. Instills in others a positive “bias for change” by personally modeling the change, reinforcing people for proposing changes, and rewarding those who identify and implement positive change initiatives.
Technical Competencies
Strategy Formulation: Chooses the most appropriate course of action for the realization of organizational goals and objectives, thereby supporting the achievement of organizational vision.
Building Teams: Selects cross-functional team members from every area of expertise (engineering, quality, regulatory, project management, marketing, etc.) as needed across multiple sites while championing team accomplishments and achieving all project goals on time and within budget.
Budget Management: Successfully managed budgets of up to $2M in support of organizational goals and achievements. Earned numerous bonuses for coming in on time and under budget for project, departmental, and global initiatives.