Plans and conducts microbiological activities concerned with the quality control and quality assurance of medical device manufacturing and design processes, materials, and products by performing the following duties.
- Develops and initiates standards and methods for testing, and evaluation.
- Interpreting, reacting and communicating process data
- Proficiency with bioburden, product endotoxin, and biological indicator sterility testing required.
- Provides technical support and writes protocols and reports in the area of sterilization and biocompatibility.
- Provides support in the above technical areas as a member of the design and manufacturing project teams.
- Performs review of supplier quality information in order to qualify both the vendor, as well as, vendor supplied product and services.
- Performs quality reviews and improvements of documentation for compliance with stated regulations, requirements, including company and vendor quality manuals and standard operating procedures.
- Develops new approaches to solve problems identified during quality activities.
- Communicates significant issues or developments identified during quality activities and provides recommended process improvements to management.
- Prepares reports to communicate involvement and results of quality activities. (CAPAs, NCMRs)
- Directs technical and administrative workers engaged in quality activities
- Maintains a working knowledge of government and industry quality codes and standards.
Bachelor's degree from four-year college or university in Microbiology or Biology with 3-5 years of related experience and/or training; or equivalent combination of education and experience. Medical device experience is preferred.
In order to provide equal employment and advancement opportunities to all individuals, employment decisions at LeMaitre Vascular will be based on merit, qualifications, and abilities. LeMaitre Vascular does not discriminate in employment opportunities or practices on the basis of race, color, religion, sex, national origin, age, disability, sexual orientation, gender identity, breastfeeding or related medical conditions, religious dress, military or veteran status or any other characteristic protected by law.
This policy governs all aspects of employment, including selection, job assignment, compensation, discipline, termination, and access to benefits and training.