Quality Sterilization Engineer - Contract
Grand Rapids, MI
DISHER – Manufacturing Technology Solutions /
DISHER DEN/Contract /
On-site
Quality Sterilization Engineer (Contract) - Grand Rapids, MI
DISHER is partnering with a customer to find a detail-oriented Quality Sterilization Engineer. This role is responsible for overseeing and carrying out sterilization validation and environmental monitoring tasks to ensure adherence to relevant ISO standards and internal protocols.
What it’s like to work here:
Make a positive difference! It’s why we exist. We are always looking for teammates who are eager to use their diverse set of talents with our customers, coworkers, and communities. We want to leave this world better than we found it.
What you'll get to do:
- Oversee sterilization and reprocessing projects, validations, and monitoring in alignment with Quality System requirements.
- Maintain corporate sterilization practices per international standards (e.g., ISO 11135, ISO 11137, ISO 17665) and regulatory requirements.
- Coordinate validation and testing activities, serving as the primary contact with laboratories and sterilization partners.
- Conduct and document assessments and validations for product and process changes affecting sterilization.
- Maintain comprehensive records of internal and vendor compliance, including validation reports, product assessments, monitoring, nonconformances, and CAPAs.
- Assist manufacturing in defining infrastructure requirements to ensure effective contamination control.
What will make you successful:
- Knowledgeable of FDA and ISO guidelines for the sterilization assessment of medical devices required.
- Working knowledge of terminal sterilization methods (ISO 11135, ISO 11137, etc) required.
- Bachelors Degree
- 2-5 years of experience in engineering, quality, or manufacturing
DISHER is a nationally recognized engineering, manufacturing technology, and technical recruiting firm based in Zeeland, Michigan. Our diverse team of top talent comes alongside clients within multiple industries to solve their unique challenges. DISHER truly is a great place to work. Our mission? To Make a Positive Difference with our customers, coworkers, and communities. Every day we strive to leave this world better than we found it. It is what motivates our caring team and unifies our culture.
