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Job Responsibilities
1. Lead product development team, supervise laboratory work for product development staff, and mentor new technical staff.
2. Plan and perform design verification and analytical validation studies for In Vitro Diagnostics products.
3. Develop, test, and refine prototype products.
4. Generate test protocols, review and analyze results, and produce V&V reports according to technical guidelines and quality management system requirements.
5. Plan daily activities, ensure adequate supplies, and organize proficiency testing within the laboratory.
6. Perform work in accordance with defined processes and laboratory procedures.
7. Ensure compliance with existing quality processes.
8. Conduct investigative work to support reagent kits as required.
9. Maintain detailed experimental records.
10. Travel to other sites or countries for knowledge transfer.
What We Offer
* Learning and development opportunities to advance your career.
* Private health insurance.
* Life and long-term disability insurance.
* Company pension contributions.
Qualifications
* Proven experience working with analytical equipment such as HPLC or UPLC; experience with LC/MS/MS is a plus.
* Ability to operate under a Quality System and knowledge of Good Laboratory Practice (GLP).
* Knowledge of design control processes and experience in regulated environments (5+ years preferred).
* Experience in R&D environments (pharmaceutical or medical device) is advantageous.
* Familiarity with laboratory procedures, including gravimetric and volumetric preparations.
* Proficiency or substantial experience with Microsoft Excel.
Desired Experience
* Product development and design experience.
* Experience in an IVD R&D environment or clinical laboratory.
* Understanding of quality management systems like ISO13485 & 21CFR820.
* Knowledge of Non-Conformance, Change Control, and CAPA systems.
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