Job Description

Join to apply for the Quality Specialist role at STERIS Healthcare United States

At STERIS, we help our Customers create a healthier and safer world by providing innovative healthcare and life science product and service solutions globally.

Position Summary

The Quality Specialist is responsible for supporting quality functions at a site to ensure compliance with ISO 9001, ISO 13485, MDSAP, FDA 21 CFR Part 820/211, EU MDR, and other standards. This includes document control, record retention, calibration, inspection, customer complaint investigations, audit coordination, supplier quality, customer assessments, and risk management. The role may also involve tracking quality data and supporting management review processes.

Responsibilities

• Complete document control transactions.
• Manage customer complaint investigations and documentation.
• Facilitate CAPA and NCR investigations, coordinating documentation as needed.
• Review DHRs and support batch record release.
• Manage record retention, calibration activities, and site inspections.
• Coordinate internal and external audits.
• Support supplier quality and customer assessments.
• Track and analyze site quality data.
• Support Lean initiatives and other duties as assigned.

What STERIS Offers

We value our employees and offer a comprehensive benefits package, including:

• Market competitive pay
• Paid time off and holidays
• Health, dental, and vision benefits
• Disability coverage
• 401(k) with company match
• Maternity/Paternity leave
• Additional benefits like pet insurance, tuition reimbursement, and career advancement opportunities

Requirements

• Associate degree
• At least two years of experience in a regulated industry (e.g., FDA/ISO 13485)

The pay range is $55,250.00 - $77,437.50, with potential bonuses or commissions. Pay is based on experience, education, certifications, and other factors.

For assistance with the application process, contact 1 (440) 392-7047. We are an Equal Opportunity Employer committed to diversity and inclusion.

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