This position is responsible for advising management on the actions necessary to maintain compliance and certification to the Medical Device licensure standards as well as develops the written policies and procedures regarding these requirements. Trains existing and new Team Schein members in quality procedures and practices. Monitors quality practices and procedures to ensure that they are adhere to and are in compliance with the requirements of Medical Device licensure certifications in all Henry Schein centers, warehouses and WICORP.
- Advises management on the actions necessary to maintain compliance and certifications to the Medical Device licensure standards.
- Develops the written policies and procedures relating to the Medical Device licensure. Maintains records, policies and procedures in appropriate locations and ensures destruction of outdated and inaccurate records as appropriate.
- Responsible for updating, revising and maintaining the written Medical Device licensure policies and procedures in accordance with the change control process at the centers and WICORP through Power DMS.
- Trains new hires and existing Team Schein members on appropriate Medical Device licensure operational procedures. Researches and understand the job functions of each position within the centers and WICORP to demonstrate job tasks accurately, according to these procedures.
- Prepares for and coordinates periodic internal and external quality audits.
- Recall processing; ensures all recalls are responded to and processed timely including any and all corrective actions.
- Participates in special projects and performs other duties as required.
- 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 WorldWide Business Standards.
- Adhering to Company policies, procedures, and directives regarding standards of workplace behavior in completing job duties and assignments.
Exceptional understanding of the job and ability to apply knowledge and skills to complete a wide range of complex tasks. Complete tasks in creative and effective ways. Complete assignments and facilitate the work activities of others; may coordinate work beyond own area. Apply acquired knowledge of procedures and external regulations. May provide back-up process support for the Supervisor.
Consistently work on complex and unique assignments requiring independent action and a high degree of initiative to resolve issues. Make recommendations for new procedures. Analyze more complex technical or non-technical problems and suggest solutions where precedent may not exist.
Work under minimal supervision and may act independently to determine methods and procedures on new assignments. Often act as a facilitator and team leader and may provide informal feedback. Provide training as needed.
MINIMUM WORK EXPERIENCE:
Typically 5 or more years of related experience.
Typically High School education, vocational training and/or on-the-job training. Bachelor's degree preferred.
GENERAL SKILLS & COMPETENCIES:
- Excellent time management skills and the ability to prioritize work
- Ability to set clear team goals, delegate tasks and set deadlines
- Very good attention to detail and accuracy
- Customer service oriented and ability to work with and resolve complex issues
- Ability to plan and arrange activities
- Excellent interpersonal communication skills
- Excellent written and verbal communication skills
- Ability to maintain confidential and highly sensitive information
- Ability to work in a team environment
- Ability to multi-task
- Ability to manage conflict
- Capacity to work effectively under pressure
- Good analysis and problem solving skills
- Oversee multiple and/or complex projects
- Identify and recommend continuous improvement opportunities
- Establish productive working relationships at multiple levels within the organization
SPECIFIC KNOWLEDGE & SKILLS:
- Good reading, writing, and computer skills.
- Good communication (written/verbal) skills.
- Detail oriented and accountable for making accurate decisions under set guidelines.
- Good problem-solving skills.
- Ability to follow instructions, work under stress, and handle multiple assignments.
- Ability to read fine print and differentiate products with similar characteristics (size, color, vendor code).
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 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.
For more information about career opportunities at Henry Schein, please visit our website at: (please click on the apply button below)
Job Field: Sales/Telesales