Overview: An exciting opportunity to become part of a dynamic team responsible for the R&D of IVD products, involved in analytical development, product verification and validation, and on-market support.
Salary: Competitive salary with company pension contributions, private health insurance, life and long term disability insurance.
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 quality management system requirements.
* Plan day-to-day activities, ensure sufficient supplies of materials to carry out tasks etc 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 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 knowledge transfer.
In return you will receive:
* Learning and development opportunities to further your career.
* Competitive salary.
* 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.
Company Description:
Waters Corporation is the world's leading specialty measurement company, pioneering chromatography, mass spectrometry and thermal analysis innovations serving the life, materials, and food sciences for more than 60 years.
We strive to unlock the potential of our employees' careers. Our global team is driven by purpose, striving to be better, learn and improve every day in everything we do.
Diversity and inclusion are fundamental to our core values at Waters Corporation. We are united by diversity and thrive on it for the benefit of our employees, our products, our customers, and our community.
We are proud to be an equal opportunity workplace and are an affirmative action employer. We are committed to equal employment opportunity regardless of race, color, religion, sex, national origin, sexual orientation, age, marital status, disability, gender identity, or protected Veteran status.