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
STERIS is recruiting for a fixed-term Quality Technician to join our team in Tullamore
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/or ISO 11135 and other applicable regulatory standards. Quality Technicians assist in identifying, documenting, and investigating non-conformances, Customer complaints, CAPAs and internal/external audit findings. They work with operations and quality team members to perform and document problem-solving investigations and continuous improvement initiatives. In addition, to performing run releases, Quality Technicians may execute review of calibration and operating logs.
The Quality Technician has specific and general responsibilities and authorities in respect of the quality system and the document control function. This will include issuing all controlled documents, including procedures, validation protocols and reports. They will also perform general clerical and reception duties including corresponding with customers, audit the document control system including its users for compliance, analysis of data using Microsoft Excel.
Duties
1. Perform Document control Duties including Review and issuing of Documents and Archiving.
2. Executes Customer specification updates and direct Customer communications when delegating for the Quality Engineer/Quality Manager.
3. Coordinates and participates in Quality investigations, associated problem-solving activities and continuous improvement initiatives.
4. Carry out Internal Audits and investigations into internal/external audit observations.
5. Analyzes and trends Quality data from local and global systems.
6. Assist in the development of new quality system policies and procedures, as well as, identify and manage revisions to existing quality system policies and procedures.
7. Assist in execution of quality system programs (i.e. calibration management, training administration).
8. Overall responsibilities include commitment to ensure external and internal requirements are met according to documented policies, procedures, standards and regulations.
Complete other duties as assigned.
Duties - cont'd
Education Degree
Associate's Degree in Engineering General or Science
Required Experience
Minimum of five (5) years of experience in manufacturing or processing environment or other technical/scientific field. Associate's Degree in a related scientific/technical field required
or
7 years relevant technical/scientific experience with a high school diplomas in lieu of an Associate Degree will be accepted.
STERIS is a leading global provider of products and services that support patient care with an emphasis on infection prevention. WE HELP OUR CUSTOMERS CREATE A HEALTHIER AND SAFER WORLD by providing innovative healthcare, life sciences and dental products and services. STERIS is a $5 billion, publicly traded (NYSE: STE) company with approximately 17,000 associates and Customers in more than 100 countries.
STERIS strives to be an Equal Opportunity Employer.