Vyaire Medical is seeking an experienced Sterilization Engineer for its growing enterprise. The Sterilization Engineer is responsible for providing direction and leadership to the different Vyaire Medical business units to maintain sterile product and related quality and regulatory compliance within the company. In addition, the associate will support the establishment and administration of quality management pertaining to the biocompatibility program.
This position would report to the Manager of Biocompatibility and CDS with a dotted line to the Director of Global Quality.
In particular you can expect to:
- Establishing and directing corrective actions and product disposition as it pertains to sterilization deviations and sterilization related product quality issues.
- Establishing and directing corrective actions and product disposition as it pertains to cleaning and disinfection deviations and related product quality issues.
- Providing sterility assurance and biocompatibility clearance resource support for the administration of sterilization supply chain qualification / maintenance, product design control qualification as well as R&D product development/ new product launch.
- Providing manufacturing site related external audit (i.e. FDA, TUV, BSI etc.) support as it pertains to sterilization qualification/maintenance, sterile product release and biocompatibility clearance.
- Applying state of the art techniques to create a compliant, efficient, and cost-effective sterilization supply chain.
- Qualifying reusable device related sterilization and cleaning processes that comply with FDA requirements and customer requirements/capabilities.
- Identifying, qualifying, and managing contract sterilization as well as biocompatibility clearance and sterilization related contract laboratory test suppliers.
- Designing and implementing sterilization related quality systems which comply with corporate policies and applicable external standards.
- Establishing quality system documentation required for the qualification/implementation and maintenance of sterilization processes, sterile product release, and biocompatibility clearance as they pertain to compliance per applicable external standards/regulations.
- Developing, validating, and implementing new / state-of-the-art test methods to support Vyaire’s sterility assurance, cleaning-disinfection, and biocompatibility clearance programs.
- Provide support to external suppliers on establishment and maintenance of qualified sterility programs and processes.
You will have the opportunity to:
- Improve patient outcomes
- Meaningfully impact the company’s short-term and long-term success
- Grow your role as you see fit
- Learn everything there is to know about respiratory medical device manufacturing
- Create an inspiring workplace
To be successful, you will need:
- Knowledgeable of industrial sterilization modalities (i.e. Ethylene Oxide, Radiation, Dry Heat, and Moist Heat sterilization).
- Maintains expertise regarding the requirements of all applicable external standards (i.e. FDA, ANSI/AAMI/ISO and BS/EN) that pertain to medical device sterilization process validation and biocompatibility clearance.
- AAMI committee membership regarding sterilization and biocompatibility clearance related working groups is highly preferred.
- Must have good communication skills.
- Location: Mettawa, IL & Irvine, CA.
- Travel: 10 - 25%
- Physical Demands: May require light physical effort as in periods of prolonged standing, sitting at files or work tables or bending, stooping, or reaching and/or occasional lifting of light items (i.e. up to 30 lbs.). May require some exposure to chemicals used in manufacturing processes.
Irvine, CA, Mettawa- HQ