Quality Engineering Supervisor

2 weeks ago


Ontario, California, United States STERIS Full time

Company Overview:
At STERIS, we are dedicated to assisting our clients in fostering a healthier and safer environment through our innovative healthcare and life science solutions.

Position Overview:
The Supervisor of Quality Engineering plays a pivotal role in the implementation and management of the quality management system. This includes overseeing processes, leading projects, and guiding team members to uphold and enhance the quality system in alignment with various regulatory standards such as ISO 9001, ISO 13485, FDA regulations, and others.

Key Responsibilities:
1. Direct daily operations and provide guidance to Quality Associates, ensuring technical support and mentoring.
2. Maintain oversight of product accuracy and compliance, managing all product review and approval processes.
3. Oversee the site's quality system through data analysis, protocol reviews, and final report approvals.
4. Conduct internal audits and ensure adherence to quality regulations and standards across facilities.
5. Collaborate with regulatory agencies and lead customer audits, ensuring effective remediation plans are in place.
6. Foster a culture of continuous improvement, engaging in facility-level and global initiatives.

Qualifications:
- Bachelor's Degree in a scientific or related technical field.
- A minimum of 8 years of experience in Manufacturing/Quality Engineering or Quality Systems.
- Proven experience in regulated industries, particularly in medical devices.
- Strong knowledge of ISO standards and FDA regulations.

What We Offer:
At STERIS, we value our employees and are committed to their long-term growth. We provide competitive compensation, annual bonuses, comprehensive health benefits, and opportunities for professional development.

Join us in our mission to enhance patient care and safety through innovative solutions.



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