Government, Regulatory and Code, Healthcare, Quality, Quality Engineering
4 Year Degree
This position is responsible to develop and implement systems to ensure products or services are designed and produced to meet or exceed customer expectations and 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 improvements to the company’s quality management system procedures including Nonconformance Material processes, Customer Complaint handling, Supplier Management, Process Validation, Measurement Systems Analysis and other quality engineering duties. This role will also be responsible to directly contribute to the implementation of the company’s quality system processes related to CE Technical Files, including Risk Management Files, Clinical Evaluations, Post Market Surveillance and Periodic Safety Reports. In addition, this role will be responsible to perform and mentor others in performing thorough Root Cause Analysis, Corrective Action planning and implementation and Verification of Effectiveness planning and implementation. This Corrective Action process will apply to internal nonconformities, product complaints, supplier quality issues, and will also provide engineering analysis and support in verification, validation and problem solving.
Engages in continuous improvement activities by identifying opportunities and recommending improvements to product design and manufacturing processes. Provides ongoing quality engineering support throughout the product lifecycle, including risk management, design and manufacturing changes and CAPA investigations.
Drives supplier quality improvement by providing engineering analysis related to component specifications and root cause analysis. Partners with key suppliers and manufacturing personnel to reduce defects and improve yield. Participates in supplier selection and qualification processes, including supplier quality audits.
Develops processes for the effective generation of metrics, including established Key Process Indicators, for use within the Quality Department.
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. Implements problem solving methodologies to reduce internal and external defects.
Provide quality engineering insight and guidance on product development, product improvement and process improvement projects. Ensures validation of key design inputs including usability, reliability, performance, manufacturability, safety and effectiveness.
Plan, control and assure product and process quality in accordance with quality principles and best practices, including process planning, material control, acceptance sampling, measurement systems and process validation. Identifies and implements product and process controls consistent with the outcome of the risk management process.
Maintains knowledge of relevant quality and regulatory standards and augments quality system processes to meet changing requirements, including the Medical Device Regulation, US FDA, MDSAP and others as required. Creates technical documentation and reports to support regulatory requirements, including Clinical Evaluation Reports, Post Market Surveillance Reports, Periodic Safety Reports and other analysis as required.
Supports computer system validation and stays current with validation regulatory requirements.
Participates in special projects and perform other duties as required.
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.
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.
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.
MINIMUM WORK EXPERIENCE:
Typically 5 to 7 or more years of increasing responsibility in terms of any applicable professional experience.
Typically a Bachelor's Degree or global equivalent in related discipline. Master's degree or global equivalent a plus. May hold one or more industry certifications; professional certification may be required to advance.
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 ISO 13485:2016, 21CFR820, MDR and other global regulatory requirements.
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.
Experience in product verification/validation, process validation and test system development and implementation. 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.
Past experience in developing appropriate trending related to operational and product quality. Previous success in driving improvement through root cause analysis and CAPA projects.
Past experience in the creation of technical documentation to support the European Medical Device Regulatory and related Technical Files, including Clinical Evaluation Reports, Post Market Surveillance Reports and Periodic Safety Reports.
Strong understanding of best practices related to supplier quality and supplier development.
General knowledgeable in computer system validation and related regulatory 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.
In addition to the essential duties and responsibilities listed above, all positions are also responsible for:
Meeting company standards pertaining to quantity and quality of work performed on an ongoing basis, performing all work related tasks in a manner that is in compliance with all Company policies and procedures including World-Wide Business Standards.
Adhering to Company policies, procedures, and directives regarding standards of workplace behavior in completing job duties and assignments.
Perform the following duties in a professional way, supporting Ortho Organizers’ Quality Policy. Must understand, follow and comply with regulatory requirements as applicable to various processes. An understanding of FDA Quality System Regulations (21 CFR 820) and ISO Standards (ISO 13485) is required.
TRAVEL / PHYSICAL DEMANDS:
Travel typically less than 10%. 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.
Additional Salary Information: DOE
Internal Number: Job Number: R115704
About Henry Schein Orthodontics
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