Initiates and completes technical activities leading to new or improved sterilization processes to meet strategic goals and objectives of the company. Prepares reports, publishes, and makes presentations to communicate findings.
Understands engineering principles theories, concepts, practices and techniques. Develops knowledge in a field to become a recognized leader or authority in sterilization and applies this knowledge in leadership roles in the company.
Applies technical knowledge to innovate, design, and develop processes and procedures.
Assesses sterilization process capabilities, prioritizes process improvement opportunities, and innovates and implements process improvements on platform or derivative projects.
Executes and supports the functional deliverables associated with the PDP/TDP, Project Management, and Quality Systems.
Supports technical reviews.
Ensures proper documentation is completed to meet quality systems requirements. (e.g., Technical Reports, FMEA’s, etc.)
Writes and reviews experimentation and validation protocol and reports, applicable to products and sterilization processes.
May serve as a core team member or extended team member on new product projects or process improvement initiatives related to sterilization.
Provides assistance and support to the sterilization Operations, Regulatory, and Quality groups as required.
Other duties as required.
Required qualifications:
Bachelor of Science degree in Microbiology, Biochemistry, or related discipline
3+ years of experience in roles related to Sterilization and Microbiology
Strong troubleshooting and problem-solving skills
Experience with IQ, OQ and PQ processes
Experience with industrial Ethylene Oxide sterilization processes and equipment and technical knowledge of other sterilization modalities
Comfortable working with internal and external vendors
Pro-active, energetic, self-assured professional with high personal integrity and ability to collaborate, influence and develop positive interpersonal relationships
Preferred qualifications:
Master of Science degree in Microbiology, Biochemistry is an asset
Demonstrated understanding of medical device regulatory requirements and quality systems