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**:
This position is responsible for assisting in administration of the quality functions at the site in accordance with the requirements for ISO, FDA QSR, and STERIS policies.
This would include but is not limited to: review quality records (i.e.
Device History Records), inspection, complaint investigation, record management, data trending, and document control functions.
**Duties**:
To review batch documentation after processing and to ensure that errors problems and anomalies are fully investigated and documented.
To be responsible for product release for all processes at site.
To ensure Quality System in Production is in compliance with STERIS Procedures, Standards and any Applicable Laws.
To initiate, investigate, control and analyse non-conformance reports in collaboration with Site QA Manager, ensuring all relevant parties are informed and where appropriate, to ensure corrective action, in collaboration with all departments involved, is implemented and that it is effective
- To initiate, investigate, control and analyse the recording and investigating of Customer complaints in collaboration with Site QA Manager.
Where justified Customer complaints, to ensure corrective action, in collaboration with all departments involved, is implemented and that it is effective_
To support the Site QA Manager, in conjunction with the technical groups, to verify the conformity of all process validation documents (PQ) and in collaboration with Validation Department and the Site QA Manager, to ensure the need for validation is identified and ensuring that the appropriate action is taken.
To support the Site QA Manager in Quality and GMP training of all site personnel.
To develop, support and maintain the Production Employee Training Program about Quality Guidelines.
To identify and report any failures in the implementation of the quality system to the Site QA Manager and Operations Management.
To investigate such matters and recommend appropriate corrective action, in collaboration with the Site QA Manager.
To support and facilitate Audits (Regulatory Inspections, Audits by Customers, audit to Supplier) in collaboration with the Site QA Manager.
Ensure that the internal audit program is executed as per plan and perform audits as required in collaboration with the Site QA Manager
**Duties - cont'd**:
Ensure that the internal and external calibration schedule is executed for applicable instrumentation, in collaboration with the Site QA Manager
To support the Site QA Manager to manage and formalise all process changes.
To monitor Production and Quality performance periodically and provide a report to the Site QA Manager on a regularly scheduled basis; monitor day to day CAPA reporting to ensure timely closure.
To support Site QA Manager to ensure that plant re-qualification / verification is executed as per Quality Management System requirements.
To support the Site QA Manager to implement, monitor and report on Customer service related corrective actions as required.
To support the Site QA Manager to review each Quality Agreement with the Customers.
To work in close co-ordination with the Site Manager (Production) and Customer Support.
To inform immediately the Site QA Manager and the Country Quality Manager ITA in case of critical issues.
To support the Site QA Manager and the Country Quality Manager ITA to Implement continuous improvement activities in agreement with the Operation Manager.
To support the Site QA Manager and the Country Quality Manager ITA to provide and maintain service excellence to Customers; provide professionalism and courtesy at high level; attend any meeting with the Customers supporting the Site QA Manager and the Country QA Manager.
**Education Degree**:
- High School Diploma or GED
**Required Experience**:
- One (1) year experience preferred in a regulated industry (i.e.
FDA/ISO 13485)
- Associate's degree in related technical field (i.e.
Engineering, Chemistry, Biology) preferred.
- Ability to work in a fast-paced environment with strict deadlines
- Technical Excellence (Learn) - Analyzes and solves technical problems.
Seeks input from more experienced individuals to improve quality of deliverables.
Generates detailed, high quality technical documentation (i.e.Complaints, CAPAs).
- Good level of English
LI-VP1
**Preferred Experience**:
**Skills**:
STERIS is a leading provider of products and services that meet the needs of growth areas within Healthcare: procedures, devices, vaccines and biologics.
We exist to fulfill our MISSION TO HELP OUR CUSTOMERS CREATE A HEALTHIER AND SAFER WORLD.
STERIS is a $3B, publicly traded (NYSE: STE) company with approximately 16,000 associates and Customers in more than 100 countries.
STERIS strives to be an Equal Opportunity Employer.