Job Description

Join Our Mission

Step into the crucial role of a Quality Assurance Laboratory Specialist at STERIS, where your mission will be to uphold and maintain the highest quality standards across our facility. This pivotal role ensures compliance with ISO 9001, ISO 13485, MDSAP, FDA 21 CFR Part 820/211, and EU MDR regulations, supporting both manufacturing and servicing operations.

A Day in Your Life

From 2:00pm to 10:30pm, Monday through Friday, you'll dive into problem-solving investigations and conduct in-process sub-assembly and final Quality Control tests. Collaborating with operations to troubleshoot production line stoppages will be part of your daily adventure. You'll scrutinize device history records, ensure precise execution of calibration activities, and manage environmental monitoring processes.

What You'll Do

• Champion production line Quality investigations and devise effective problem-solving strategies.
• Analyze and document product and process non-conformances while participating in the Material Review Board.
• Handle the review and release of batch records and verify processing instructions and dosimeter placements.
• Record, retrieve, and manage Quality data, ensuring flawless data entry and system use.
• Commit to additional tasks as needed, enhancing operational efficiency.

Qualifications

• Possess an Associate degree with one year of technical production experience, or bring over 3+ years of relevant expertise.
• Demonstrable experience in ISO regulated environments and cleanroom settings, adhering to demanding deadlines.
• Excel with proficiency and showcase top-notch troubleshooting abilities.

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