Sterilization Quality Manager

Sterilization Quality Manager

This key hire reports to the Senior Director of Quality Assurance for a fast-emerging neurological imaging company based in the greater Boston area and easily commutable from North or West Boston Metro Area.

This opportunity offers an executive leadership team with proven experience commercializing new medical technologies, a strong capital partner and thus lower financial risk, and a ground breaking innovation that directly impacts and drastically improve patient care for serious neurological disorders.

The primary duties and responsibilities of this role:

• Improve, implement and maintain the company’s Sterilization processes, environmental monitoring and contamination control processes and systems in accordance with applicable regulatory requirements and standards
• Support validation of sterilization processes in accordance with all applicable regulatory and industry standards
• Manage validation of upgrades to clean rooms and administer an effective environmental monitoring program
• Contribute to quality systems, procedures and coaching/training of company staff to support safety objectives, high quality of product and all applicable regulatory and safety standards in area of expertise
• Review manufacturing quality records in support of lot release
• Support sterile barrier packaging validations
• Participate and contribute to company compliance activities such as corrective actions, non -conformances and complaints
• Contribute to the on going continuous improvement of the company’s microbiology and sterilization procedures
• Other duties as assigned

EXPERIENCE/SKILLS/REQUIREMENTS:

5 or more years of experience as a knowledgeable Microbiology and Sterilization professional with key working knowledge in the following areas:

• medical device product manufacturing in a Class 8 cleanroom
• quality systems guidelines in ISO 13485 and cGMP
• sterilization process management including validation
• validating and/or monitoring clean rooms and administration of environmental monitoring programs
• Comprehensive understanding of FDA regulations as related to sterilization of medical devices
• Background and experience in Quality/Assurance/Quality Control systems in a regulated environment
• Experience with e-beam sterilization a strong plus; other sterilization or microbiology or contamination control experience may be acceptable