The Senior Sterilization Quality Engineer is responsible for managing the Environmental, Microbiology and Sterilizations systems and practices through the implementation of the appropriate Medical Device standards. The candidate will be the subject matter expert in these areas and coordinate all activities related to them across the organization.
Principle Duties and Responsibilities:
Facilitates the timely completion of quarterly Dose Audits, monthly Bioburden and annual re-certification process for all sterilization modalities.
Works closely with engineering investigation teams to assure the timely closure of technical investigations.
Front room ISO and FDA compliance audits;
Knowledge of AAMI ST72, ISO 11135, ISO 11137, ISO 11737-1, ISO 10993-7, AAMI ST72
Works with R&D, manufacturing and quality to bring new product and changes to existing products to completion as the sterilization SME.
Coordinates monthly quarterly and annual environmental monitoring testing
Responds to Request from Regulatory bodies for supplemental information or clarification of existing submittals.
Works with sterilization vendors in order to resolve ay non-conformances
Identify and implement improvements to the environmental monitoring and sterilization systems
Prepare metrics and trending reports for Sr. Management on a monthly basis.
Provide direction regarding Corrective and Preventative Actions that relate to the product microbiology, sterilization and environmental monitoring.
Interprets updates to applicable international standards and guidelines and implements them into the quality system.
Validate clean room
Assist management on departmental projects, as necessary.
Help investigate issues with Manufacturing daily
Other duties as specified.
Bachelor and Engineering degree required
5 years of quality engineering work experience in a regulated environment. Medical device experience preferred
Knowledge of lean, six sigma, kaizen and continuous improvement initiatives a plus
Excellent verbal and written communication skills
Strong organizational skills; must be detailed-oriented
Ability to execute tasks in a timely manner under general supervision
Strong knowledge of Microsoft Office Suite and Adobe Acrobat