Director, Quality Assurance - Manufacturing

may take all reasonable and prudent steps necessary to maintain compliance with company and product registration requirements, with appropriate notification to, and/or direction from their direct supervisor.
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* KEY RESPONSIBILITIES:

** Oversee the Quality Management Systems of multiple entities ensuring compliance with global MDSAP requirements as applicable. Direct and oversee the research for applicable FDA, ISO and ASTM/ANSI standards to ensure the company’s ongoing compliance with U.S. and International Regulatory Requirements (Medical Devices Directives, Medical Device Regulations, and FDA QS requirements).
** SPECIFIC KNOWLEDGE &

SKILLS:

** Knowledge of ISO 9000 certification and maintenance. Knowledge of ISO 13485 certification and maintenance. Knowledge of the European Medical Device Regulation 2017/745. Knowledge of US FDA Quality Management System Regulation
** GENERAL SKILLS &

COMPETENCIES:

*** Outstanding management and leadership skills and ability to attract, retain, motivate, develop, mentor and coach team members for high performance
* Outstanding verbal and written communication skills and ability to resolve disputes effectively
* Outstanding presentation and public speaking skills
* Expert independent decision making, analysis and problem solving skills
* Understand, interpret and act on financial information and external trends that contributes to business profitability
* Plan and manage complex and successful projects; understand available resources, develop timeline, budget and assign areas of responsibility
* Lead teams to achieve company goals and solve complex business issues in creative and effective ways
* Expert planning and organizational skills and techniques
* Communicate effectively with senior management and key stakeholders
* Excellent negotiating skills and ability to effectively manage internal and external relationships
* Ability to influence, build relationships, understand organizational complexities, manage conflict and navigate politics
* Broad professional and managerial skills with a full understanding of industry practices and company policies and procedures
* Lead and develop virtual teams
* Expert in multiple technical and business skills
* Strategic planning skills
** MINIMUM

WORK EXPERIENCE:

** Typically 12 or more years of increasing responsibility and complexity in terms of any applicable professional experience; 5 or more years of management experience. Experience managing the quality management systems of multiple manufacturing locations is preferred.

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* PREFERRED EDUCATION:

** Bachelor's Degree or global equivalent in Engineering , Science or related technical discipline. Master's degree preferred. RAPS and ASQ or other equivalent Certifications preferred.
** TRAVEL / PHYSICAL DEMANDS:
** Travel typically 25% or more. Office environment. No special physical demands required.

Knowledge of MDSAP country specific regulatory requirements Over  Henry Schein borrowed $500 to start a corner pharmacy in Queens, New York, nearly 30 miles from Melville, New York, where our corporate headquarters resides today. In the depths of the Great Depression, Henry and his wife Esther made a bold bet on their future all while living their values of helping health happen and caring for their team and the community they served.

Their belief paid off far beyond what Henry and Esther might have dared to imagine in 1932. Henry Schein is now a Fortune 500 Company powered by a network of people and technology to be the world’s leading provider of health care products, services and solutions to office-based dental and medical practitioners.  Since our founding we have stayed true to Henry and Esther’s values which has allowed us to evolve, expand, and grow our Company.

Now serving more than 1 million customers in 33 countries and territories, the Company's network of trusted advisors provides more than 1 million customers globally with more than 300 valued solutions that help improve operational success and clinical outcomes.  We invite you to join approximately 25,000 Team Schein Members, who are critical to our success and are at the core of our  as our founders would have wanted.

We live…