|Title:||Quality/Regulatory Affairs Coordinator|
|Job Location:||Algonquin, IL|
Young Innovations is a manufacturer and marketer of high quality dental equipment and supplies. With an outstanding reputation for quality, our company has a broad portfolio of market leading products across a variety of categories.
We are seeking a talented, self-led, and energetic Quality/Regulatory Affairs Coordinator to join our team at our Algonquin, IL location. The Quality/Regulatory Affairs Coordinator is responsible for managing the complaint handling unit (CHU) functions for the Algonquin facility. The QRA Coordinator will facilitate change in the Quality Management System (QMS) by monitoring various logs (e.g., DCR, CAPA, Change Control) to ensure productive activity and compliance with due dates.
- Act as the Customer Complaints and Feedback System Administrator. This includes:
- Performing daily reviews of complaint cases to determine the need for Medical Device Reporting per 21 CFR 803,
- Maintaining the complaint database,
- Assigning individuals or teams to investigate customer complaints,
- Work with the Customer Service Representatives to communicate updates and satisfy customer needs, and
- Tracking and updating statuses of all open complaints for trending and management review purposes.
- Act as the Document Control System Administrator. This includes:
- Ensuring adequate review, approvals, and training for all document changes.
- Ensuring the latest documentation is distributed to appropriate users,
- Ensuring obsolete documentation is removed from distribution, and all related documents are filed appropriately.
- Tracking and updating statuses of all document changes for trending and management review purposes.
- Act as Change Control System Administrator. This includes:
- Monitoring the CAPA and change control logs to ensure assignment completion,
- Tracking and updating statuses of all CAPA and change control records for trending and management review purposes.
- Perform ad hoc reviews of records to ensure system compliance.
- Manage regulatory certifications and registrations (e.g., FDA, ISO, JPAL, Health Canada, Italian Ministry of Health Database).
- Conduct internal audits
- Bachelor’s degree in a quality, business, science or engineering discipline desirable.
- 2+ years of relevant quality/regulatory experience in Medical Device or Pharmaceutical Industry or equivalent combination of education and experience.
- Knowledge of 21 CFR and ISO 13485.
- Proficient in Microsoft Office Suite (Excel, Power Point, Word and Outlook)
- Strong attention to detail.
- Ability to work in a team environment as well as alone with little direction.
- Excellent verbal and written communication skills to all levels of the organization.
- Strong organizational skills required.
Young Innovations, Inc. is an Equal Opportunity Employer and E-Verify participating employer