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.
The Quality Specialist supports, and reviews quality systems processes and serves to improve awareness, visibility, and communication on quality initiatives to support assigned quality goals and priorities.
Responsible for change control and ensuring all change requests are dealt swiftly and timely closed out.
Responsible for document management systems
Create new Quality System procedures/instructions as well as monitor and maintenance of existing processes.
Logging and monitoring change requests, CAPAs, SCARs and other records as applicable.
Coordinate and support on-site audits conducted by external providers
Assist in creating and maintaining internal audit records including tracking CAPA activities as required.
Develop, recommend and monitor corrective and preventive actions
Assist in and prepare for the execution of Notified Body audits and track progress of responses
Assist in investigating quality issues and interact with products suppliers regarding these
Review and investigate customer complaints, determine product failure root causes and evaluate risk of failures
Ensure that the quality system is understood and applied throughout the organisation on all levels by personnel concerned
Duties - cont'd
Maintenance of technical files, OBL files and test reports of product conformity according to MDD 93/42/EEC and amendments 2007 (be aware of the latest regulation)
Assist with international product registrations
Collect and compile statistical quality data. Analyse data to identify areas for improvement in the quality system.
Interpret, implement and evaluate the adequacy of the quality assurance standards
Prepare reports to communicate outcomes of quality activities
Identify training needs and organize training interventions to meet quality standards
Assure ongoing compliance with quality and industry regulatory requirements
Creates, revises and maintains records systems necessary to monitor product quality and process control throughout location’s operation. Ensures required records are maintained.
Any other duties required by the role
Certifications an advantage including Quality Auditor, Quality Engineer, Quality Improvement Associate, Six Sigma
Quality inspection, auditing and testing experience
Experience with implementation of corrective action programs
Product or industry-specific experience
Strong computer skills including Microsoft Office, QA applications and databases
Knowledge of tools, concepts and methodologies of QA
Familiar with ISO 13485 and MDD
Data collection, management and analysis
STERIS plc is a $3B, publicly traded (NYSE: STE) organization with more than 12,000 employees worldwide.
STERIS strives to be an Equal Opportunity Employer.