Director of Regulatory and Quality Assurance

Company: ids Biotech Dental
Location: Englewood
Posted on: August 2, 2022

Job Description:

We are a fast-growing dental products company looking for a smart, energetic Director of Regulatory and Quality Assurance to join our team. This is a fast-paced work environment, as we are currently undergoing tremendous growth. Our employees have the responsibility to proactively identify areas for improvement, to create the most efficient and effective work environment, so we can continue to offer excellent service and innovative marketing to our customers. The successful candidates responsibilities will include:

• Provides leadership and direction regarding all activities of the Quality and Regulatory operations of the business, inclusive of foreign operations.
• Promotes Quality Assurance (QA) and Regulatory Affairs (RA) and is the highly visible, approachable champion of QA/RA to both internal and external customers
• Openly collaborates with internal departments regarding continuous improvement specific to the QMS and by supporting employees to challenge the status quo to generate new ideas.
• Assist and manage our 510k submissions.
• Perform product quality complaint investigations
• Write and review Standard Operating Procedures (SOPs)
• Generate data for Annual Product Review (APR)
• Assist with vendor audit and qualification program to ensure suppliers and contractors are adhering to client contract guidelines and regulatory requirements
• Create, review and revise product specifications, artwork and labeling. Work with vendors to ensure artwork and labeling are current and any revisions are implemented according to client and vendor change management processes
• Support external vendors in the writing, review and approval of validation protocols and reports
• Examines and evaluates Quality and Regulatory risks and notifies Executive Management proactively/in a timely manner of potential non-compliance and other findings that could have an adverse impact to the company
• Responsible for certifying the Company's products and services meet established quality levels and clearance standards, as well as ensuring all necessary regulatory applications and statuses are maintained and filed
• Acts as the Company liaison to all applicable regulatory and auditing bodies for communications pertaining to the regulatory process(es) for products requiring regulatory approval, certification, or clearance.
• Serves as CAPA administrator to ensure timely and effective administration of the DI CAPA program. Facilitates investigation activities to determine root cause of non-conformances.
• Proactively engages in business/industry trade groups and organizations ensuring relevant trends are understood and communicated throughout the organization.
• Continually assesses, tracks and provides regular updates to the executive management team on Quality Objectives relating to quality, regulatory, compliance, and applicable customer service functions
• Initiate change controls for products (i.e., master documents, component specifications, equipment changes, process changes, labeling changes)
• Provide assistance to contractors with respect to regulatory agency inspections when directed
• Inspection of finished product
• Manage Design Control processes
• Develop, lead and supports projects that improve processes and systems for improving quality and reducing costs and improve efficiencies
• Develop product and quality measures and reports for annual management review
• Reviews and conducts analysis, testing and inspection procedures, applies Metrology Statistical Methods to diagnose and implement corrective/preventive actions for continuous improvement
• Communicates with operations and other value stream members; recommends improvements including design changes, documentation, and inspection methods or criteria
• Conduct investigations and coordinate the activities of special projectsJob RequirementsThe QUALIFICATIONS for the QUALITY ASSURANCE MANAGER (QA MANAGER) INCLUDE:
  Bachelor's degree;3-5 years of Quality Assurance experience in a Medical Device environmentExcellent communication and interpersonal skills; ability to work effectively across functional areas with various levels of employeesSalary is commensurate with experience.
  
  David Singh COOE david.singh@idsimplants.com
  
  

Keywords: ids Biotech Dental, Tenafly , Director of Regulatory and Quality Assurance, Executive , Englewood, New Jersey