Sr. Microbiologist, Quality Assurance

Overview

Plans and conducts microbiological activities concerned with the quality control and quality assurance of medical device manufacturing and design processes, materials, and products.

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.

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.