TITLE:Quality Assurance Officer
(6-month contract - maternity cover)
REPORTING TO: Quality Assurance Manager
JOB DESCRIPTION OVERVIEW:
The role will be responsible for supporting the routine management & continuous improvement of the Quality Management System in accordance with the requirements of ISO 13485:2016 and all other applicable regulatory requirements (inc. MDD 93/42/EEC & MDR 2017/745).
The key aspects of the role will cover (but not be limited to) the handling of Non-Conformance Reports; Customer Complaints; QCIS Improvements & support for the QA Manager in matters of a quality and regulatory compliance, in accordance with business needs.
• Non-Conformance Reports [NCR's] - management of NCR's from initiation through to corrective/preventive actions (inc. supplier notification & action where applicable) and effectiveness review.
• Complaint Handling [CC's] - management of complaints inclusive of appropriate root cause investigation; corrective/preventive actions (inc. supplier notification & action where applicable) and effectiveness review.
• Quality Control Inspection Sheet (QCIS) Development - improvement of the inspection protocols within QC, in-line with complaints data and routine reject reporting
• Reviewing/Auditing, Updating & Writing QMS SOP's
• Support the management & continuous improvement of the QMS as per ISO 13485:2016 & MDD/MDR requirements
• Quality Assurance / Control experience, within the Medical Devices sector (essential).
• An understanding /experience of the working requirements of ISO 13485 & other international and/or regulatory standards (essential).
• Excellent attention to detail with the ability to work across functionally across the business, as well as suppliers & customers.
• Excellent oral & written communication skills, and ability to communicate/present at different levels of the business.
• Good IT skills and knowledge of MS Office [inc. word; excel; powerpoint]
• Able to work independently & prioritise workload in-line with business requirements.
• Internal Auditing experience (desirable).
• Ability to work under pressure, and prioritise workload
• Willingness to learn, develop and undertaken challenges in line with business needs
• Dedicated, focused and committed, with a friendly & helpful demeanour
• Flexible approach to working additional hours in line with business needs