Assist the Quality department in supporting the Quality Management System (QMS) by providing efficiencies in administration and promoting continual compliance to regulatory and client requirements with the internal departments, and suppliers.
Locations (2)
United Kingdom
Kings Norton, England, United Kingdom
Compensation
Salary: Up to £42,000.00 depending upon experience.
Responsibilities
Provide QA support to internal departments to ensure activities are undertaken in compliance with GDP and Arvato procedures
Provide quality assurance support/advice to operational departments in support of compliance to process
Initiate and maintain change control, deviation and Corrective and Preventative Action (CAPA) records ensuring effectiveness of activities proposed
Provide administrative support to QA scheduling of suppliers, internal audits, and annual reviews
Collate data to be used in reports, investigations, key performance indicators (KPIs), and other quality metrics
Responsible for maintaining accurate, compliant, and well-organized controlled documents and quality records that support Thorne's Quality Management System and manufacturing operations.
Responsibilities
Create, format, edit, route, finalize, file, and maintain controlled documents within Thorne's Quality Management System.
Maintain controlled documentation including SOPs, work instructions, forms, specifications, formulas, master manufacturing records, policies, and other quality-related documents.
Coordinate with subject matter experts and cross-functional stakeholders to ensure controlled documents are accurate, complete, and appropriately reviewed.
Ensure controlled documents progress through established review, approval, and finalization processes.
Coordinate periodic document reviews and ensure required reviews are completed within established timeframes.
Requirements
High school diploma or GED
Nice to have: electronic Quality Management Systems
The Quality Engineer is responsible for supporting and maintaining the Quality Management System within a European medical device distribution centre.
Compensation
enjoy many benefits, such as flexible working hours and competitive salaries
Responsibilities
Support day-to-day quality oversight of receiving, inspection, storage, picking, packing, shipping, returns, quarantine, and product release activities within the distribution centre
Verify that distributed medical devices meet applicable requirements before release, including CE marking, product labelling, instructions for use, UDI, importer information where applicable, and required documentation
Ensure storage and transportation conditions remain aligned with manufacturer requirements, including temperature, humidity, segregation, cleanliness, and protection from contamination or damage
Manage or support nonconformance investigations, deviations, product holds, quarantine decisions, and disposition activities in collaboration with Operations, Regulatory Affairs, Supply Chain, and Quality leadership
Support complaint intake, escalation, investigation coordination, trend review, and communication with manufacturers or responsible economic operators as required
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