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Title Microbiologist

Hiring Organization: Connexion Systems & Engineering

• Duration: Perm
• Pay rate:
• Job Location: Bedford, MA
• Job# 14519

Microbiologist

• 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.
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• 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 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.
• Qualifications
• 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.

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