Quality Supervisor – Medical Devices
Full job description
Recruitment South East
Salary: £42,600 per year
Our client is an international eye health products company based. They are one of the world’s largest suppliers of contact lenses, lens care products, pharmaceuticals, and other eye surgery products.
They are currently looking for a Quality Supervisor to join their team in Hastings.
The role
The site Quality supervisor has direct responsibility for the site Quality system and Quality Leadership at the Hastings facility. The successful candidate will ensure that a site Quality Management System is maintained for product manufacturing, control, storage, and primary distribution processes in accordance with applicable MDD regulatory requirements, ISO 13485, upcoming UKCA, MDR and associated Standards and our client’s Global Quality requirements.
Provide support & guidance to the Brexit, UKCA and MDR projects as applicable
Key activities/responsibilities:
Success in this role will be measured through:
* Achievement of Quality Measures established for the manufacturing operations (i.e QPI)
* Successful achievement of all quality audits by internal and external regulatory agencies.
* Effectively interfacing with staff to achieve goals / objectives of this role including achievement of overall goals for the operation.
* Successful implementation of standards, guidance & regulations for the Hastings site and products
Job Responsibilities:
* Establishes and maintains a compliant site Quality system, which allows for the timely supply of goods, and which meets our client’s and legal regulatory requirements.
* Lead and oversee all Quality and Compliance activities for the Hastings manufacturing site, including contribution to the site Operations budget.
* Implement and maintain policies and procedures for both internal and outsourced calibration/analysis/service processes. Review and approve all site Standard Operating Procedures, ensuring their conformance with the applicable, ISO standards, EU Directives and Regulations, UKCA and our client’s requirements.
* Establish and maintain effective cross-functional relationships with other support functions, as required: site Operations leadership, site engineering, EH&S. Includes effective relationships with global functions: Global Operations and Engineering, Global Regulatory, R&D Leadership.
The role will report to Global Quality Operations
Qualifications & experience
* Experience in manufacturing Quality or Quality systems supporting a manufacturing site preferably in the Medical Devices field (minimum 3 years’ experience).
* Qualified Lead Auditor and statistical knowledge an advantage
* Knowledge of applicable ISO Standards, Medical Device Directive and the Medical Device Regulation
* Desired: Examples of quality leadership and including successful interactions with regulatory agencies.
* Lead Auditor experience, including supplier a distinct advantage
* Key team player role in management of Hastings operation but able to work on own initiative
Salary between £42,600 and £40,000 pa, depending on skills and experience + 10% bonus and great perks.
To apply for this job please visit definitejobs.co.uk.