Quality Assurance/Regulatory Affairs Manager
The QA/RA Manager’s primary role is to assist in the implementation and management of the document control function to include quality system procedures, forms, device master record documentation (DMR documentation), design history file documentation (DHR), and quality record management. This position additionally includes review of product DHRs and product release related to contract manufactured product as applicable, management and follow-up of open corrective/preventive actions and non-conformance reports (NCRs), assisting in the execution of internal audits, assisting in the facilitation of QA/RA related training as required, supporting annual management review, assisting in reviewing and updating supplier files, and supporting external audits/inspections and regulatory affair submissions/product registrations and licensure as required.
The Director of RA/QA.
- Manage the control of quality system documentation (procedures, work instructions, forms), DMR documentation, DHR documentation, and quality records
- Ensure complaint documentation and records are complete and in compliance with regulatory/quality requirements prior to closure
- Review production device history records for accuracy and completeness, document the release of finished product from contract manufacturers as required
- Support RA/QA management with CAPA review board forums, as deemed required and monitor completion of tasks, ensuring CAPA files remain updated as necessary
- Escalate incomplete or overdue CAPA tasks to the management of the responsible task owner
- NCR documentation management (assigning NCR numbers, ensuring appropriate signatures are obtained, NCR closure)
- Assist in executing internal audits and participate in and support external audits and inspections
- Assist in facilitating RA/QA related training as required
- Support and participate in annual management reviews
- Review supplier files and update as deemed necessary
- Contribute to product safety, product quality, and customer satisfaction related decisions (both data-based and risk-assessment-based decisions)
- BS/BA degree in related discipline or equivalent combination of education and experience
- Strong demonstrated working knowledge and experience in EN ISO 13485, and the FDA cGMPs (21 CFR §820), EU MDD/MDR, CMDCAS