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.**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.

**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 GreatDepression, 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 andterritories, 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 those values by ensuring that our culture focuses on the

of our team, which we accomplish by providing a

for individuals to develop and contribute authentically, with opportunities to and the communities where we live and work.

No matter the role you are seeking, we encourage you to come be a part of a team that makes the world a healthier place.Henry Schein embraces diversity and is committed to providing equal opportunity to employees and applicants. If you are unable or limited in your ability to complete the application process, including the use or access of , as a result of a physical or mental impairment, you can request reasonable accommodations.Please e-mail the appropriate email address below with the type of accommodation you are requesting. Please include your first and last name, phone number, position for which you are interested in applying and geographic location in your request.US Candidates: jobsupport@henryschein.com UK and Ireland Candidates: UKHSHRRecruitment@henryschein.co.ukAustralia and New Zealand Candidates: APACCareers@henryscheinone.comMalaysia Candidates: CNHR@henryschein.comItaly Candidates: risorse.umane@henryschein.it### Workplace Remote TypesIt is important to us to offer different types of work arrangements. Please see the types we offer below: #J-18808-Ljbffr