The position is responsible for ensuring that core functions of Quality Assurance are consistently in compliance with regulatory requirements. This involves assuring quality standards (FDA, ISO, CMDCAS, Medical Device Directive (MDD) and Canadian Medical Device requirements) with respect to such processes as Inspection, Document Controls, CAPA, Nonconforming Materials, Complaints and Internal Auditing. This position is granted the authority by the Director, RA/QA to take any actions required to fulfill the scope, duties and responsibilities of this position.
ESSENTIAL RESPONSIBILITIES & ACCOUNTABILITIES:
1. Develop, establish and maintain QA processes, procedures and controls ensuring that performance and quality of products conform to established standards and regulations
2. Oversee the documentation process for Device History Records; propose, draft, review and approve new or revised SOPs, job instructions and related forms relative to the quality assurance program or other programs which may impact the quality assurance program
3. Provide guidance to Operations personnel in interpreting governmental regulations, agency guidelines and internal policies to assure compliance
4. Direct and supervise daily activities of QA/QC staff involved in receiving, in-process and final inspection, complaint investigation, Corrective and Preventive Action (CAPA) process and document control to ensure compliance to quality standards/regulations
5. Responsible for hiring and training quality assurance personnel as required supporting the above processes
6. Generate ideas and leads efforts at the facility to identify root causes of quality issues and implement processes to resolve and prevent issues
7. Participate in Corrective and Preventive Action teams in response to concerns identified through complaints, nonconforming materials or other various concerned activities
8. Facilitate the Change Control Board (CCB) meetings to review and disposition Change Orders (CO)
9. Lead ISO internal audit, train and develop internal auditors and issue audit reports
10. Participate in facility and QSR inspections by the Food and Drug Administration (FDA), Notified Body and internal GMP audits
11. Evaluate employees through performance reviews, ongoing coaching and feedback methods. Analyze and resolve or assist employees in solving work issue. Maintain discipline, morale and team relationship within the QA/QC group
12. Provide quality data, trending/statistical reports to the RA/QA Director
13. 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.
Maintain quality system in compliance with all applicable regulatory standards (FDA QSR, ISO 13485, MDD, CMDCAS, Canadian Medical Device requirements) and other relevant requirements throughout the facility
Four-year degree in sciences or health-related field with 3-5 years related experience; or 8-10 years prior experience as a Quality Assurance Supervisor in a medical device regulated facility.
Medical device experience a must, preferably in the dental device industry. Expert knowledge of quality system regulations, i.e., FDA QSR, ISO 13485
Specialized Knowledge and Skills:
Demonstrated ability to lead and manage 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 general business periodicals, professional journals, technical procedures, or governmental regulations. Ability to write reports, business correspondence and procedures. Ability to effectively present information and respond to questions from groups of managers, clients, customers and the general public.
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.
Job Field: Quality Assurance/Regulatory