Nicholas Henderson Email & Phone Number

Melbourne, Victoria, Australia

Axxin provides diagnostic platforms for biomedical applications that bridge the gap from research to market with world leading innovation, capability and cost effectiveness. Axxin IVD instruments are used worldwide in partnership with leading biomedical and pharmaceutical companies for LFA/immunoassay and molecular diagnostics applications.Duties and Responsibilities:• Creating company Production Test SOP and records for spectrometers, lateral flow immunoassay readers and other technology prototypes that meet ISO 13485 / FDA 21 CFR Part 820 and Design Master Record (DMR) requirements• Managing Production Test team in testing Axxin products to meet shipment targets and relevant company KPI: - Reviewing Production Test activities and records to ensure they meet above quality standards - Identifying, recruiting, training, supervising and mentoring new and existing staff for Production Test functions - Planning and documenting work allocation schedules and resourcing needs for Production Test team - Conducting annual performance reviews of Production Test staff• Investigating with other engineering teams (hardware, software, firmware, mechanical) to find root cause solutions for issues raised in testing for product and process improvement• Meeting with Production Assembly team, monitoring key metrics, applying statistical techniques and seeking continuous improvement to increase production yield, efficiency, quality, and reliability• Reviewing project milestones and deadlines with Axxin management/CEO to ensure on time delivery of customer orders• Managing calibration and maintenance of testing equipment, reference samples and Master instruments across a range of projects• Assisting external auditors on regulatory compliance• Producing reports for management reporting on the above• Participating in production planning and QMS meetings• Engaging with customers to provide reports on project shipping schedules, forecast and status

Melbourne, Australia

Perform internal audits on the organisation's Quality Management System (QMS) and contribute to its continual improvement.Duties and Responsibilities:- Understanding the requirements of ISO 13485:2016 and FDA 21 CFR Part 820 for Medical Devices CGMP- Conducting internal quality system audits- Gathering evidence through observation, process identification, sampling and questioning- Writing formal reports on the compliance of the management system against the audit standards- Following up on the corrective and preventive action process (CAPA)

Melbourne, Australia

Duties and Responsibilities:- Leading fire and evacuation drills- Implementing, monitoring and improving effective emergency procedures

Fairfield, Australia

Duties and Responsibilities:• Coordinating and running final testing, calibration and repair of spectrometers, lateral flow immunoassay readers and other technology prototypes as projects arise. Responsible for final sign off of each instrument DHR before shipping• Developing company SOP and test records that comply with ISO13485, FDA 21 CFR 820 Part 820 and Design Master Record (DMR) requirements for medical devices• Liaising with other engineering teams (hardware, software, firmware, mechanical) to troubleshoot, identify root cause, repair instrument faults and feed back into instrument design• Responding to complex technical support requests such as instrumentation troubleshooting or test/assay design• Assisting in R&D and continuous quality improvements for instrument design, software and testing protocols• Overseeing reference samples and chemical reagents used in final testing• Managing customer shipments including packing, shipment documentation, and transit carrier bookings• Recording key metrics from production assembly to final testing and support issues, reviewing monthly statistics and reporting to management• Technical demonstrations of biomedical products to visitors, detailed customer training and travel to trade shows (e.g. MMTC 2018 and AACC 2018, 2019)• Training of new staff and participating in technical/design review meetings

University Of Melbourne

Assisted with upgrading the University's IT system. Liaised with software/technical teams, migrated over data and performed a variety of follow-up support.

University Of Melbourne, Molecular Biology & Biotechnology Group

Summer internship at an ARC Centre of Excellence, to support research into drought resistant properties of certain strains of rice. Microscopically dissected shoot apical meristem from plant seedlings, extracted rice anthers, and undertook PCR and further genomic analysis.

South Yarra, Melbourne

Researched the Australian biotechnology sector and deliver detailed portfolios regarding key emerging biotechnology companies and diagnostic technologies.

Master Of Science (Biotechnology), Science

First class honours Dean's Honours List Industry Project: "Opportunities and lessons for Sienna Cancer Diagnostics from a study.

Bachelor, Science

First class honours Majoring in Genetics/Immunology

International Baccalaureate