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Responsibilities
* Lead product development team, supervise laboratory work for product development staff. Train and mentor new technical staff.
* Plan and perform design verification and analytical validation studies in the laboratory for In Vitro Diagnostics products.
* Develop, test and refine prototype products.
* Generate test protocols, review and analyze results, and generate V&V reports per current applicable technical guidelines and the quality management system requirements.
* Plan day to day activities, ensure sufficient supplies of materials to carry out tasks and organize all proficiency testing within the laboratory.
* Carry out work in accordance with defined processes and laboratory procedures.
* Ensure that all work is compliant within the existing quality processes.
* Perform investigative work as required by the organization to support reagent kits.
* Maintain detailed experimental records.
* Travel to other sites/countries for the transfer of knowledge.
In Return You Will Receive:
* Learning and development opportunities to further your career.
* Private health insurance.
* Life and long-term disability insurance.
* Company pension contributions.
Qualifications
* Proven experience of working in a laboratory with analytical equipment such as HPLC or UPLC. Practical experience of LC/MS/MS would be an advantage.
* Ability to operate under a Quality System and knowledge of Good Laboratory Practice (GLP).
* Knowledge of the design control process and/or with demonstrable effective experience in a regulated environment (5 years+ ideally).
* Experience working in an R&D environment (pharmaceutical or medical device) would be advantageous.
* Familiarity with basic laboratory procedures including gravimetric and volumetric preparations.
* Microsoft Excel training or substantial experience utilizing Excel is required.
Experience Desired
* Product development and design experience - Experience working in an IVD R&D environment or a Clinical laboratory would be advantageous.
* Understanding of the requirements of quality management systems - ISO13485 & 21CFR820.
* Knowledge of Non Conformance, Change Control and CAPA systems.
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