Government, Regulatory and Code, Healthcare, Quality, Quality Engineering
This position is responsible for supervising the day-to-day inspection activities of incoming material and in-process and final products to ensure product specifications are met in addition to managing the returned and nonconforming materials processes to ensure timely completion of all activities as required by governmental regulations.
ESSENTIAL RESPONSIBILITIES & ACCOUNTABILITIES:
Supervise the daily activities and assignments of the quality control team to include 1) quality inspections, i.e., incoming, in-process and final, 2) receiving, documenting, processing and moving returned good and products in the RMA system, 3) managing the nonconforming material process and conducting MRB meetings, as required, to ensure compliance to quality standards and governmental regulations, i.e., FDA QSR, ISO 13485, Canadian Medical Device Relation.
Act as liaison between the Warehouse/Manufacturing and QA departments. Provide feedback on accuracy of CIS and QIR’s to ensure they are current and revise as necessary. Ownership of KPI (key performance indicators) tracking for the QC team.
Participate in facility and QSR inspections by the Food and Drug Administration (FDA), Notified Body and internal GMP audits.
Interact with multi-functional groups inside and outside the Quality department.
Train QC inspection staff members on quality procedures.
Evaluate employees through performance reviews, ongoing coaching and feedback methods.
Provide quality data, trending/statistical reports to the Quality System Supervisor/Quality Manager.
Participates in special projects and performs other duties as required.
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 Worldwide Business Standards.
Adhering to Company policies, procedures, and directives regarding standards of workplace behavior in completing job duties and assignments.
PHYSICAL ACTIVITIES / WORK ENVIRONMENT:
This position will be working in an office environment, utilizing typical office equipment. While performing the duties of this job, the employee is regularly required to stand; use hands and fingers to handle, or feel product; reach with hands and arms. The employee is occasionally required to walk; stoop, or kneel, and talk and hear. The employee must occasionally lift and/or move up to 10 pounds. Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision, depth perception, and ability to adjust focus. While performing the duties of this job, the employee may be exposed to moving mechanical parts. The noise level in the work environment is usually moderate.
Two-year Associate Degree with 1 - 2 years of related experience; or 3 - 5 years prior experience as a quality supervisor/lead in a medical device regulated facility.
Medical device experience a must, preferably in the dental device industry.
Knowledge of quality system regulations, i.e., FDA QSR, ISO 13485
SPECIALIZED KNOWLEDGE AND SKILLS:
Demonstrated ability to lead and supervise a staff of employees
Ability to effectively problem-solve through critical thinking and root-cause analysis with minimal direction and make decisions with confidence
Excellent organizational skills and attention to detail
Strong communication skills, both oral and written
Ability to prioritize, multi-task and adapt to change
Ability to work within budget constraints and to work with minimal guidance to perform job function
Ability to work effectively in a team environment and build strong working relationships
High degree of initiative and self-motivation with a strong sense of accountability
Word processing skills, including Microsoft Word, Excel, and PowerPoint
Ability to read, analyze, and interpret instruction for use, technical procedures and governmental regulations. Ability to write routine reports, business correspondence and procedures. Ability to effectively present information and respond to questions from groups of managers, employees of the organization and customers.
Ability to define problems, collect data, establish facts, and draw valid conclusions. Ability to interpret a variety of instructions furnished in written, oral, diagram or schedule form.
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
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