The Quality Officer (QO) is responsible for implementation, maintenance and continuous improvement of the organization’s Quality Management System (QMS). The Q officer will report to the QRA & Market Access Manager who remains accountable and responsible for the development of the quality strategy and is the company’s representative for regulatory and quality compliance during design, development, verification, validation and manufacturing of IVD medical devices to ensure a high level of process and product quality.
- Coordinate the development, implementation and continuous improvement of the Antelope Quality Management System (QMS) to meet necessary regulatory requirements for In Vitro Diagnostic Medical Devices (IVD), such as the European IVD Regulation (2017/746), ISO13485, and the FDA Quality System Requirements (21 CFR 820).
- Coordinate, support, review and follow up the required validation efforts, such as Equipment Qualification (e.g. IQ/OQ/PQ), Computerized System Validation (software tools and medical device software) or Process Validation.
- Ensure continuous improvement, accuracy and maintenance of the Electronic Documentation Management System (EDMS); act as primary contact in the support (internal and external) and control its validated status
- Plan, organize, prepare, conduct and follow-up internal Audits
- Handle and follow-up Problem Report towards the QMS and as applicable, initiate and follow-up of corrective and preventive actions
- Handle and follow up Change Control Reports towards the QMS
- Provide training and ongoing mentoring to team members on the Quality Management System
- Support in the compilation and (independent) review as applicable, of the Product Design History Files (DHF)
- Support critical supplier audits, as deemed necessary
- Organize, prepare, conduct and follow-up the QMS management review & analysis of data, and compile Key Performance Indicators.
- Report progress on continuous improvement programs.
- Dialogue / interact with External Certification Bodies
- Act as a primary contact when 3rd party audits take place on-site
- Provide quality assurance inputs to team members and promote awareness in terms of customer requirements.