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.
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:
SPECIFIC KNOWLEDGE & SKILLS:
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:
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.