Quality Assurance Manager
5 days ago
STERIS is seeking a highly skilled Quality Manager to lead our quality improvement efforts in our Spartanburg, South Carolina facility. As a key member of our team, you will be responsible for implementing and maintaining state-of-the-art quality practices, ensuring compliance with domestic and international standards, and driving continuous improvement initiatives.
Key Responsibilities:- Lead the organization's Quality staff to ensure compliance to the overall Quality Management System and drive continuous improvement.
- Work closely with site senior management to provide strategic direction and development of the organization's quality strategies and tactics.
- Provide quality viewpoints and opinions on future service/technology offerings.
- Manage the CAPA, complaint and non-conformance handling processes to ensure customer responsiveness and process improvements.
- Lean and manage Regulatory Agency and Notified Body inspections and drive the creation and implementation of sustainable and effective remediation plans.
- Bachelor's Degree in a related scientific/technical field.
- Minimum of 5 years of people leadership experience, required.
- Minimum of 2 years of experience in a Quality leadership role.
- 10 years of experience working in an ISO certified environment required.
- 10 years of combined Manufacturing/Quality Engineering and/or Quality Systems experience.
- 10 years of experience with medical device or other regulated industries preferred.
- Sterilization experience preferred.
- Working knowledge of FDA QSR/ EUGMP regulations strongly preferred.
STERIS is a leading global provider of products and services that support patient care with an emphasis on infection prevention. We offer a competitive salary, healthcare benefits, tuition assistance, paid time off, holidays, matching 401(k), annual merit, and incentive plans. Join us and help write our next chapter.
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