OverviewPlans 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.
