This position is responsible to implement and manage the company’s quality assurance policies, procedures and methods to evaluate and improve the quality of complex products, materials, components and/or operations using standard procedures (e.g. 9001:2008, ISO 13485:2003, etc.).
Oversee the preparation, documentation, and conduction of Quality Assurance audits of Distribution Centers, joint Ventures, X-Ray Centers, private label manufacturers, non-manufacturing suppliers of Medical Devices and Pharmaceuticals.
Direct and oversee Quality Assurance audits to ensure the effective and timely facilitation of suppliers and internal quality audits and follows-up on CAPAs/Observations.
Oversee suppliers to assure the quality of their products, materials, components and/or operations.
Lead in the monitoring of supplier performance efforts and recommend changes to improve the production process.
Stay current with new or potential business opportunities, and prepare for all QA activities.
Research applicable FDA, ISO and ASTM standards to ensure the company’s ongoing compliance with the U.S. and International Regulatory Requirements (Medical Devices Directives and FDA QS requirements).
Provide ongoing direction and guidance to the team and provide guidance and development opportunities as needed.
Select, develop, and evaluate TSMs to ensure the efficient operation of the department.
Typically 7 or more years of increasing responsibility and complexity in terms of any applicable professional experience; 1 or more years of management experience.
Bachelor's Degree or global equivalent in Information Technology or related technical discipline. Master's degree or global equivalent preferred.
GENERAL SKILLS & COMPETENCIES:
Attract, retain, motivate, coach and develop team members for high performance.
Broad and wide-range of professional and managerial skills with a full understanding of industry practices and company policies and procedures.
Use skills to lead teams to achieve company goals in creative and effective ways.
Excellent planning/ organizational skills and techniques.
Excellent analysis and problem-solving skills.
Excellent decision-making skills.
Excellent negotiating skills.
Excellent writing and communication skills.
Ability to lead virtual teams.
Communicate effectively with senior management and key stakeholders.
Ability to Influence, build relationships, navigate politics and manage conflicts.
Understand, interpret and act on financial information that contributes to business profitability.
Ability to plan and manage successful projects, manage risks, costs, time and project teams.
SPECIFIC KNOWLEDGE & SKILLS:
Knowledge of ISO 9001 and 13485 certification and maintenance and related FDA requirements.
Henry Schein, Inc. is an Equal Employment Opportunity Employer and does not discriminate against applicants or employees on the basis of race, color, religion, creed, national origin, ancestry, disability that can be reasonably accommodated without undue hardship, sex, sexual orientation, gender identity, age, citizenship, marital or veteran status, or any other legally protected status.
Internal Number: R105042
About Henry Schein
Henry Schein, Inc. (Nasdaq: HSIC) is a solutions company for health care professionals powered by a network of people and technology. With more than 22,000 Team Schein Members serving more than 1 million customers globally, the Company is the world's largest provider of Business, Clinical, Technology and Supply Chain solutions to enhance the efficiency of office-based dental, animal health, and medical practitioners. The Company also serves dental laboratories, government and institutional health care clinics, and other alternate care sites.
A Fortune 500® Company and a member of the S&P 500® and the Nasdaq 100® indexes, Henry Schein's network of trusted advisors provides health care professionals with the valued solutions they need to improve operational success and clinical outcomes. The Company offers customers exclusive, innovative products and solutions, including practice management software, e-commerce solutions, specialty and surgical products, as well as a broad range of financial services. Henry Schein operates through a centralized and automated distribution network, with a selection of more than 120,000 branded products and Henry Schein private-brand products in stoc...k, as well as more than 180,000 additional products available as special-order items.
Headquartered in Melville, N.Y., Henry Schein has operations or affiliates in 34 countries. The Company's sales reached a record $12.5 billion in 2017, and have grown at a compound annual rate of approximately 15 percent since Henry Schein became a public company in 1995. For more information, visit Henry Schein at www.henryschein.com, Facebook.com/HenrySchein, and @HenrySchein on Twitter.