Job Description

Come Join our Team!


Henry Schein Orthodontics, a subsidiary of Henry Schein Inc, is a leading manufacturer of orthodontic appliances, clear aligners, and technology for the global orthodontic marketplace. We provide innovative products, services, and solutions to help orthodontic practitioners deliver exceptional care to their patients, while concurrently building successful practices. In the USA, our products are marketed to orthodontic practitioners through a strong direct sales force, and internationally, our products are sold in more than 85 countries through 160+ distributors. We are dedicated to providing the orthodontic profession with high quality, innovative products and treatment solutions, backed by attentive customer service and educational support. At Henry Schein Orthodontics everyone is part of the team, with the same goal; to improve patient care and continue to Advance the Future of Orthodontics for generations to come.

JOB OVERVIEW:

This position is responsible to develop and implement systems to ensure products or services are designed and produced to meet or exceed regulatory requirements including the US Food and Drug Administration, Health Canada, European MDD/MDR and others as required. This role will also participate in the implementation of the companys quality system processes related to CE technical files, including risk management files, clinical evaluations, post market surveillance, periodic safety reports, complaint handling, process validation, etc. This position will also interface directly with OEMs and suppliers to support the creation and delivery of compliant technical documentation to support local DHR, DMR and CE Technical Files.

KEY RESPONSIBILITIES:

Responsible for creating technical documentation intended for the creation and ongoing maintenance of the companys CE Technical Files. Documentation may include, but is not limited to, product specifications, risk management files, design verification/validation, process validation, post market surveillance, and clinical evaluations. Works closely with suppliers/partners to obtain, adopt and maintain documentation related to virtual manufacturing and OBL products.
Engages in continuous improvement activities by identifying opportunities and recommending improvements to product design and documentation processes. Provides engineering support throughout the product lifecycle, including risk management, design and manufacturing changes, clinical evaluations and post market surveillance.
Conduct periodic trend analysis and provides business impact analysis of product and process trends to monitor and take appropriate corrective/preventive actions to ensure product quality, patient safety and compliance with regulatory reporting requirements. Partners with Engineering, Operations and Supplier leadership to drive risk reduction and address trending issues.
Provide regulatory engineering insight and guidance on product development, product improvement and process improvement projects. Validates key design inputs including usability, reliability, performance, manufacturability, safety and effectiveness.
Maintains knowledge of relevant regulatory standards and augments quality system processes to meet changing requirements, including the Medical Device Regulation, US FDA, MDSAP and others as required.
Participates in special projects and perform other duties as required.

KNOWLEDGE:

Senior level professional; knowledge and full understanding of one or more disciplines and good knowledge of organization, processes and customers. Good judgment, strong analytical ability, evaluation, originality and ingenuity required to perform tasks. Know and apply the fundamental concepts, practices, and procedures of a particular field. Resolve issues and assignments in creative ways. Some assignments may be broad in nature. May serve as a resource to others to resolve complex problems and issues. May take on project co-lead role as required.

COMPLEXITY:

Work on problems of diverse scope and moderate impact where analysis of data requires a review of a variety of factors. Use best practices and knowledge of business strategy to solve complex problems; recommend solutions to business challenges. Demonstrate good judgment in selecting methods and techniques for obtaining solutions. Network with senior internal and external personnel in own area of expertise.

SUPERVISION:

Receive minimal instruction on day-to-day work and general instruction on new projects or assignments. May act as a resource to provide informal guidance for TSMs with less experience. Assignments can be broad in nature.

Qualification

MINIMUM WORK EXPERIENCE:

Typically, 5 to 7 or more years Engineering experience within the Medical device industry, including roles within quality assurance, quality engineering or regulatory affairs, as well as direct experience with processes related to the creation of Design History File and CE Technical File documentation.

PREFERRED EDUCATION:

Typically, a bachelors degree or global equivalent in Engineering (preferably Electrical or Mechanical). Masters degree or global equivalent in Engineering or MBA a plus. ASQ certification a plus.

GENERAL SKILLS & COMPETENCIES:

Strong understanding of industry practices
High proficiency with tools, systems, and procedures
Good planning/organizational skills and techniques
Good decision making, analysis and problem solving skills with ability to multi-task
Strong verbal and written communication skills
Good presentation and public speaking skills
Good interpersonal skills
Good conflict resolution skills and ability to deliver difficult messages
Ability to build partnerships at all levels within the company, begin to build partnerships externally
Resolve complex issues in effective ways

SPECIFIC KNOWLEDGE & SKILLS:

Strong working knowledge of medical device regulations including 21CFR820, MDR and other global regulatory requirements and quality system standards including ISO14971, IEC 60601 and other relevant standards.
Demonstrated success in the implementation of problem-solving methods and tools.
Understanding of the effective implementation of the entire risk management process, including the identification and implementation of appropriate controls in product development and/or operations.
Demonstrated success in leading efforts to develop post market surveillance studies, clinical evaluation documentation, and other documentation related to CE Technical Files.
Experience in the development and implementation of processes and testing meant to satisfy quality and regulatory standards in the medical device industry, as well as drive product and process quality.
Practical experience with the implementation of statistical tools and techniques.
Experience in developing appropriate trending related to operational and product quality. Previous success in driving improvement through root cause analysis and CAPA projects.
Strong understanding of best practices related to supplier quality and supplier development.
General knowledgeable in computer system validation and related regulatory requirements

PERFORMANCE REQUIREMENTS:

Typically, to advance to a new job level, TSMs must demonstrate professional behavior and should consistently be at the high-end of meets expectations or consistently exceed expectations.

TRAVEL / PHYSICAL DEMANDS:

Travel typically less than 20%. Office environment. No special physical demands required.

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.

For more information about career opportunities at Henry Schein, please visit our website at: www.henryschein.com/careers