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Agilent TechnologiesLocation: Niel, Belgium Agilent is the premier laboratory partner for a better world. We provide life science, diagnostic and applied market laboratories worldwide with instruments, services, consumables, applications and expertise. Agilent enables customers to gain the insights they seek – so they can do what they do best: improve the world around us. Information about Agilent is available at www.agilent.com. Multiplicom N.V. (as part of Agilent Technologies) is a Belgian biotech company focused on human molecular diagnostics. The company develops, manufactures and commercializes leading edge and easy-to-use genetic test kits based on the latest molecular diagnostic technologies. With its easy and reliable methodology it is enabling all molecular laboratories the implementation of personalized medicine. To strengthen our team, we are looking for a Software Quality Assurance Engineer. Your Responsibilities: • Support software product and process quality system infrastructure based on FDA, ISO 13485, EU CE IVD, China FDA, Japan PMDA and Rest of the world. Provide software QA support to three nearby sites. • Participate in new product core teams as software regulatory and quality representative. Software products include cutting edge next generation bioinformatics software's for Next Generation Sequencing, PCR, Microarray Scanner, and Variant Calling software for variety of applications like singe cell analysis, post-natal, and cancers. • Provide active feedback on Software Life Cycle Process and Software Complaint Handling Process Standard Operating Process and corresponding work instructions. • Review and approve software Project Life Cycle (PLC) deliverables like software requirements, design documents, software risk analysis, design reviews, software verification and validations as per ISO 62304, ISO 62366 and ISO 14971 requirements • Author and maintain software risk analysis throughout entire product lifecycle • Ensure compliance of validation efforts performed by internal/external validation personnel • Provide guidance on software labeling and review the software promotional materials. • Ensure successful transfer of software from development into production use • Review and approval of software related change orders • Lead customer complaint investigations related to software. Trend and monitor software complaints & CAPAs. • Lead and provide quality assurance support to software related CAPAs. • Responsible for escalating potential safety related risks to management • Participate in the internal and external ISO 13485 and FDA audits. Lead and represent QA for the software products portion of the audits. • Lead third party software validation projects requiring coordination with other functional groups • Support Automation, Implementation, Validation and Training of Quality Management System processes including but not limited to • Customer Complaints and Health Hazard Evaluation and Health Hazard Risk Assessment • Corrective Action and Preventive Action (CAPA) • Non-conforming products and Deviation Notices • Learning Management System • Assist in the development and delivery of training to employees on principles of software requirements, software risk management, and validation. Your profile: • Bachelors or Master's degree in Biological or Computer Sciences or equivalent • 2 - 3 years of software quality and regulatory work experience (industry preferred but not required) • Working knowledge of Genomics, Biological reagents, Microarrays, Next Gen Sequencing instruments, software and assay work flow. • Good knowledge of ISO 13485 and FDA QSR quality management system requirements and IVD products. We offer: • Training and development opportunities. • A commitment to work/life balance. • Total Compensation Package including medical and dental benefits, retirement programs and more. • A company with values around innovation and contribution, uncompromising integrity, trust, respect and teamwork, speed, focus, and accountability. • The diversity of cultural and individual perspectives held by our employees and their commitment to inclusion.
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