Quality Engineer

Position Overview

This is a 12-month contract role focused on supporting the quality management system to ensure compliance with standards such as ISO 9001, ISO 13485, FDA 21 CFR Part 820/211, EU GMPs, ISO 17025, ISO 11137, ISO 11135, and other regulatory requirements. The Quality Engineer leads investigations for complaints and CAPAs, drives supplier quality improvements, and facilitates continuous improvements using statistical and quality methodologies.

Key Responsibilities

• Supervise and provide technical guidance and mentoring to Quality Technicians and Senior Technicians.
• Oversee all pre-review and final release processes for products and reports conducted by quality personnel.
• Manage product and report releases involving non-conformances, lead customer communications, and steer non-conformance investigations.
• Engage in corrective action initiatives, problem-solving, and quality enhancement projects.
• Conduct internal audits at various company facilities, identify non-conformities, and prepare reports; follow up on corrective action implementation as assigned by the Quality Manager.
• Develop and revise quality system policies and procedures to maintain compliance and improve processes.
• Analyze data statistically to recommend improvements and monitor quality performance metrics.
• Train employees on quality principles, corrective actions, and statistical methods.
• Collaborate across departments and facilities on quality matters.
• Lead quality system programs including calibration, maintenance, CAPA, complaints, supplier quality, document and change control, risk management, and others.
• Ensure compliance with external and internal standards, policies, and regulations.
• Perform additional duties as assigned.

Educational and Experience Requirements

• Bachelor's degree required.
• 3 to 5 years combined experience in manufacturing, quality engineering, or quality systems; alternatively, a minimum 6 months onsite internship or cooperative experience with the company.
• Experience within medical device or similarly regulated industries preferred.
• At least 3 to 5 years working in ISO-certified environments is mandatory.
• Strong knowledge of FDA Quality System Regulation (QSR) and European GMP regulations is highly desirable.

Skills and Attributes

• Proven excellence in problem-solving and continuous improvement initiatives.
• Experience working independently and collaboratively on cross-functional teams.
• Outstanding organizational, verbal, and written communication skills.
• Proficient computer skills including Microsoft Excel, Word, PowerPoint.
• Ability to function effectively in a regulated, deadline-driven environment.
• Mathematical proficiency with fractions, percentages, ratios, proportions, and algebra applications.

Company Overview

STERIS is a global leader in providing infection prevention products and services dedicated to improving patient care and creating a safer world.

Equal Opportunity

STERIS is committed to being an Equal Opportunity Employer.