Overview
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.
Responsibilities
- 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 around sterilization and biocompatibility.
- Provides support in the above technical areas as a member of design & manufacturing project teams.
- Performs review of supplier quality information 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.
- Develop 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.
- Prepare 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.
- Adheres to company policies, procedures, and documentation requirements.
- Treats others with courtesy, sensitivity, and respect at all times.
- Other duties as assigned.
Pay range 90,000-110,000 per year plus bonus. The range provided is based on what we believe is a reasonable estimate for the base pay range for this job at the time of posting. The actual base salary pay will be based on a number of factors such as education, qualifications, certifications, experience, and other job-related factors permitted by law.
Qualifications
Bachelor's degree from four-year college or university in Microbiology or Biology
5 years of related experience. Medical device experience is preferred.
Knowledge of cGMPs.
Microsoft Office.
Fluent in English.
EEO Statement
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.
Applicants with disabilities may contact LeMaitre HR coordinators via telephone, fax, e-mail, and other means to request and arrange for accommodations. If you need assistance to accommodate a disability, you may request an accommodation at any time. Please contact LeMaitre HR at HR@lemaitre.com.
