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Summary Description
The VP, Quality Operations is a key member of the Quality Leadership Team (QLT) and the Tissue Technology (TT) Divisional Leadership Team with primary responsibility to ensure the delivery of high-quality products and services to our customers. This position has direct responsibility for quality across our Tissue Technologies division with four manufacturing sites and a network of stakeholders focusing on compliance, quality, safety, and efficiency.
Essential Duties And Responsibilities
- Create and implement best practice quality vision, strategy, policies, processes, and procedures to aid and improve business performance.
- Ensure that Quality meets or improves on budget, cost, volume, and efficiency targets (KPIs) in line with business objectives.
- Proactively drive continuous improvement activities to ensure problems are prevented and issues resolved efficiently and economically.
- Proactively work to ensure the organization has the right structure and competencies to meet the current and future needs of the business.
- Build a high-performance quality culture and team, empowering and holding direct reports and cross-functional teams accountable for product quality.
- Communicate effectively with internal and external parties regarding quality initiatives.
- Support interactions with regulatory bodies and ensure compliance with all applicable quality and safety standards.
Desired Minimum Qualifications
- Bachelor’s degree is required, in engineering, science or closely related technical discipline is preferred. A Masters degree preferred.
- 18+ years of experience leading a team (direct reports or projects) or equivalent education and years of management experience.
- Experience in highly regulated industries required, medical device and/or pharmaceutical preferred.
- Strong analytical skills, exceptional writing and interpersonal relationship skills.
- Demonstrated knowledge of FDA regulations, ISO 13485, CMDR, Medical Device Directive Regulation (93/42EEC), Japanese Pharmaceutical Affairs Law, and other national and international regulations and standards.
- Experience with direct contact with FDA and EU Notified Bodies.
- Knowledge of process design and implementation, change control, auditing, and document management systems required.
- Demonstrated organizational, management and communication skills.
- Ability to travel up to 50% if needed based on site needs.
Integra Leadership Capabilities
- Enterprise Mindset: Leaders with this capability make decisions, set priorities, and share resources based on what will benefit Integra as a whole.
- Thought Leadership: Leaders with this capability build personal credibility and utilize business acumen and customer mindset to influence the innovation and growth of the business.
- Drive Performance: Leaders with this capability drive performance and accountability through others and self.
- Enable Talent: Leaders with this capability strive to engage, support, and develop self and others, optimizing the success of individuals and teams.
Integra LifeSciences is an equal opportunity employer, and is committed to providing equal employment opportunities to all qualified applicants and employees regardless of race, marital status, color, religion, sex, age, national origin, sexual orientation, physical or mental disability, or protected veteran status.
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