About this Opportunity
We are seeking a skilled Product Development Specialist to join our dynamic team responsible for the research and development of innovative diagnostic products.
Key Responsibilities:
* Design and develop new products, ensuring they meet the highest quality standards.
* Conduct analytical validation studies in the laboratory to ensure product performance.
* Develop and refine prototype products through rigorous testing and refinement.
* Generate test protocols, review and analyze results, and create reports according to current technical guidelines and quality management system requirements.
* Plan daily activities, manage supplies, and organize proficiency testing within the laboratory.
* Carry out work according to defined processes and laboratory procedures.
* Ensure compliance with existing quality processes.
* Perform investigative work as required to support reagent kits.
* Maintain detailed experimental records.
* Create and revise laboratory Standard Operating Procedures (SOPs) as needed.
* Travel to other sites or countries for knowledge transfer and collaboration.
What You'll Gain
* Learning and development opportunities to advance your career.
* A competitive salary.
* Private health insurance.
* Life and long-term disability insurance.
* Company pension contributions.
* An Employee Assistance Program (EAP).
Requirements
* Proven experience working in a laboratory with analytical equipment like HPLC or UPLC. Practical experience with LC/MS/MS is an advantage.
* The ability to operate under a Quality System and knowledge of Good Laboratory Practice (GLP).
* Experience working in an R&D environment, particularly in pharmaceutical or medical device industries, would be beneficial.
* Familiarity with basic laboratory procedures, including gravimetric and volumetric preparations.
* Proficiency in Microsoft Excel, including the use of Macros.
Desired Experience
* Product development and design experience.
* Experience working in an R&D environment, preferably in pharmaceutical or medical device industries.
* Understanding of quality management systems, including ISO 13485 and 21 CFR 820.
* Knowledge of Non-Conformance, Change Control, and CAPA systems.