Senior Quality Assurance Engineer - Sterilization - Marlborough, MA

IPG Medical Corporation is focused on developing next-generation medical products based on its state-of-the-art technology. Headquartered in Marlborough, MA, we aspire to work together with our employees and customers to apply light in ways that improve life.

Our mission is to develop innovative medical device laser solutions that make the world a better place. To accomplish this mission, we are committed to attracting and retaining the best talent and an engaged, diverse, and thriving workforce that drives a sustainable future for our company and society.

Working at IPG Medical Group you can expect challenging projects, a motivating and friendly environment, and competitive benefits.

SUMMARY OF PRIMARY DUTIES AND RESPONSIBILITIES:

• As the Senior Sterilization Engineer, they will be the subject matter expert in product sterilization, environmental monitoring and sterile single use and re-useable medical devices and packaging validation.
• Manage validation of sterilization processes in accordance with industry standards (ISO 11137 and/or ISO 11135, ISO 11737)
• Manage validation of upgrades to clean rooms and administer an effective environmental monitoring program (ISO 14644)
• Define, approve and manage sterile barrier packaging validations (ISO 11607)
• Implement and maintain quality system processes in accordance with applicable regulatory requirements (ISO 13485 and 21CFR820)
• Review and address nonconformities related to sterilization and out of specification monitoring parameters
• Participate in compliance activities e.g., complaints, corrective actions, non-conformances
• Maintain Microbiology/sterilization procedures for continuous improvement as required by the quality system
• Drive the development of biocompatibility test protocols (ISO 10993)
• Set alert and action plans for product and environmental monitoring
• Develop and implement a training program to educate personnel in basic sterilization and controlled environment manufacturing
• Other duties as assigned

10 or more years of experience in QA.

A working knowledge in the following areas:

• Medical device product manufacturing in a Class 7 or 8 cleanroom
• Quality systems such as ISO 13485, cGMP, and FDA QSR regulations in a manufacturing environment
• Sterilization process management including validation, preferably ETO sterilization
• Validating, certifying and monitoring clean rooms
• Terminally sterilized product packaging and validation
• Medical device biocompatibility testing
• Sterilization process and vendor auditing

Must be a good communicator with experience and aptitude to work across functional teams.

EDUCATIONAL REQUIREMENTS:

• Bachelor's Degree in scientific field; microbiology preferred