Quality officer (IVD medical devices)
Quality officer (IVD medical devices)
Not applicable / Ghent Belgium
The company's technology makes it possible to detect protein markers at a consumer price-tag with the ease-of-use of a pregnancy test and with clinical lab performance. The system comprises of a small read-out device and disposable tests. The tests rely on antibody-antigen reactions on silicon photonics technology, combined with microfluidics.
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 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.
Requested competences and skills:
Master’s degree in Life Sciences (e.g. Pharmacy, Biochemistry, Bio-engineer, Engineer) or equivalent by job expertise/training
Knowledge of the ISO 13485 standard and other quality standards, as applicable in the (IVD) medical device industry (e.g. ISO 14971, IEC 62304, IEC 62366)
2-5 years in a Quality function within a related field (lab, pharma, medical device)
Solid understanding of Quality environment related to medical devices, esp. IVD; or alternatively to pharma (GMP)
Experience with development of (IVD) Medical Devices is added value
Experience with equipment qualification, computerized system validation and/or process validation activities
Experience in the maintenance of a quality management system, and implementing Quality improvements projects
Experience with Quality Software Tools
Experience in the Design Control and Risk management processes is an added value
Experience of quality system auditing
Knowledge of the FDA regulatory track and standards applicable thereto is an added value
Dutch and English language and written skills.
Excellent interpersonal skills and communication skills, written and oral, in English
Highly analytical and attention to detail
Ability to think and adapt to a rapidly changing environment and demands
Excellent understanding of MS Office (Excel, Word, PowerPoint, Outlook).