Quality Technician

STERIS; Westport; On-site; EUR 40,000 - 50,000; Full time

Job summary

A global healthcare solutions provider located in Ireland is seeking a Quality Technician to assist in managing the quality system and ensure regulatory compliance. The ideal candidate will have an Associate's Degree and strong teamwork, organizational, and mathematical skills. Responsibilities include conducting product reviews, supporting quality investigations, and maintaining detailed documentation. This role offers the opportunity to contribute to a safer healthcare environment.

Qualifications

• Ability to work in a fast-paced, regulated environment with strict deadlines.
• Ability to generate detailed, high quality documentation.
• Ability to work with others in analyzing and solving technical problems.

Responsibilities

• Conduct pre-review on incoming product to confirm compliance.
• Review and release laboratory reports, ensuring tests comply.
• Assist in quality investigations and continuous improvement initiatives.

Skills

Mathematical skills

Teamwork

Detail-oriented

Organizational skills

PC experience

Education

Associate’s Degree

Tools

Excel

Word

Job description

At STERIS, we help our customers create a healthier and safer world by providing innovative healthcare and life science product and service solutions around the globe.

Position Summary

The Quality Technician is responsible for assisting in administration of the quality management system at a site to assure adherence to ISO 9001, ISO 13485, FDA 21 CFR Part 820/211, EU GMPs, ISO 17025, ISO 11137 and ISO 11135 and other applicable regulatory standards. The Quality Technician supports production and quality operations by performing and documenting problem solving investigations, conducting pre-reviews of customer product and run set-up and final acceptance/run release through review of run records/device history records.

Responsibilities

• Conduct pre-review on incoming product to confirm compliance to the customer’s processing specifications, verify calculations, correct dose range, approved product codes, dosimeter placements and special instructions.
• In lab facilities, review and release laboratory reports, ensuring tests comply with requirements and customer requests.
• Assist in quality investigations, associate problem-solving activities and continuous improvement initiatives.
• Identify, document and investigate non-conformances to establish sustainable corrective actions and support investigations into customer complaints and internal/external audit observations.
• Assist in the development and revisions to quality system policies and procedures.
• Execute review of operating logs (spectrophotometer, pre‑conditioning, aeration), preventive maintenance schedules, maintenance work orders and site calibration activities to ensure timely and accurate recordkeeping. Escalate matters of non‑compliance to site quality lead/manager.
• Commit to ensuring external and internal requirements are met according to documented policies, procedures, standards and regulations.
• Complete other duties as assigned.

Qualifications

• Associate’s Degree.
• Ability to work in a fast‑paced, regulated environment with strict deadlines.
• Mathematical skills including ratios, proportions, basic algebra.
• Ability to generate detailed, high quality documentation.
• Ability to work with others in analyzing and solving technical problems.
• Teamwork: Collaborates with others and works in a professional manner to support team actions.
• Effectively manages work tasks, is detail oriented and strives for continuous improvement.
• Above average organizational skills.
• PC experience and working familiarity of common desktop applications including Excel and Word.

STERIS strives to be an Equal Opportunity Employer.