Production Equipment Europe is a leading industrial distributor of critical and innovative products and services to customers globally across a wide range of industries, including medical device, pharmaceutical, electronic and engineering. In order to support our business we wish to recruit a Quality Co-Ordinator. Reporting to the Quality Manager, this person will be a key member of the Quality Team and have responsibility for management and administration of the processes and documentation underpinning the Quality Management System across the group. This position will provide quality, regulatory and admin support in the areas of collation of declarations of compliance from suppliers in line with regulatory requirements and provision of such declarations to customers when requested. The Quality Co-Ordinator shall monitor and maintain the integrity of the quality system, instigating timely periodic reviews of procedures, polices and related documents.
Responsibilities
Ensure Quality Systems administration is compliant with the established ISO9001 Quality Management System.
Provide quality support to operations and customer delivery within the organisation
Liaise directly and develop collaborative relationships with Customers and Suppliers to obtain, provide and maintain records of Quality / Regulatory Documentation and Declarations.
Understanding of customer requirements in regulated environments, e.g. Declarations of Conformance in line with EU MDR, ECHA Reach, RoHS, etc.
Development of CoC Templates for New Products / Customers in line with ISO Standards and assistance in generation of CoCs when required.
Maintain product quality status of quarantined products
Participate in the internal QMS Audit process.
Participate in external audits (Customer & Regulatory).
Support the organisation in meeting the relevant regulatory requirements.
Perform miscellaneous duties as necessary in a fast-paced environment.
Required Skills:
Qualification in a Quality, Science or related discipline desirable.
Minimum of 2 years relevant experience in a Quality or related roles in a fast paced environment.
Good administration skills, with an analytical approach to work tasks
Experience of working within an ISO9001:2015 and / or ISO13485:2016 environment
Experience working with health, safety and environmental standards
Strong knowledge and application of quality system regulations and ISO standards
Ability to manage multiple concurrent projects or activities, and able to prioritise effectively.
Excellent verbal & written communication skill.
Strong attention to detail and problem-solving skills.
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