The Boerne, Texas site needs a Quality Assurance leader to ensure continuous production of products consistent with the Quality Management System, focusing on organizational compliance and meeting applicable quality requirements.
Requirements
- Strong knowledge of various standards and regulations such as ISO 9001, ISO 13485, ISO 14971, the Quality System Regulation (21 CFR Part 820), Australian Therapeutic Goods (Medical Devices) Regulations (TG(MD)R Sch3), the Brazilian Good Manufacturing Practices (RDC ANVISA 665/2022), the Canadian Medical Devices Regulations, and any specific requirements of the medical device regulatory authorities participating in the MDSAP program.
- Five (5) years quality assurance experience.
- Two (2) years quality experience in relation to medical device or In vitro diagnostics devices.
- Five (5) years proven quality experience in relation to In vitro diagnostics devices.
- Knowledgeable with ERP systems such as ProAlpha, Oracle, SAP and AS400.
- Good computer skills including Microsoft Word, Excel, Outlook.
Responsibilities
- Direct activities of the quality system to ensure compliance to both national and international requirements.
- Support the administration of the Supplier Quality Management process. Manage the Supplier program to include the selection, evaluation, and ultimate approval of new suppliers. Monitor the performance of suppliers.
- Conduct training in current Good Manufacturing Practice (cGMP), International Organization for Standardization (ISO) standards.
- Regulate document control systems including labels, IFU revisions, operating procedures, etc., and all related documents that create the Quality Management System, meeting ISO, GMP/QSR, and company directives.
- Coordinate Corrective and Preventative Actions (CAPAs) and non-conformance activities.
- Lead, maintain, and improve the QMS in line with ISO 9001, ISO 13485 and MDSAP, to ensure all aspects of the QMS are understood, implemented, and maintained by staff.
- Implement effect validation strategies in support of continuous improvement with established and evolving regulatory and company requirements.
Other
- Appointed as the local Management Representative.
- Directly manage the Quality Assurance personnel at the Boerne site.
- Fulfill Manager responsibilities in accordance with the organization's policies and applicable laws; Responsibilities include interviewing, hiring, and training employees; planning, assigning, and directing work; appraising performance; rewarding and disciplining employees; addressing complaints and resolving problems.
- Two (2) years of supervisory experience.
- Detail oriented with a high level of accuracy, efficiency, and accountability.
