Austin Vita have an exciting opportunity for a Senior Quality Engineer / QA Lead who is looking to take the next career step as the position will be a stepping stone to Quality Management. Our client is a well established Medical Device company based in Essex and the role will be site based due to the hands on nature of the work.
You will participate in daily operational quality activities and lead quality planning projects with the senior leadership team; such as EU-MDR Transition of the QMS and compliance activities. The primary role is to monitor and manage non-conformities (NCRs), CAPAs, Supplier control activities (Performance Evaluations/SCARs/Audits/Agreements), Document Control and Product Batch Release.
This position will suit someone who is comfortable in a fast-paced environment, has technical report writing experience, non-conformity investigation experience and experience of working within a 13485:2016 QMS framework. A certified lead auditor qualification is required for this role.
Key Tasks include;
- Maintain the Quality Management System according to the ISO 13485:2016 by ensuring SOPs/WIs and Forms remain current to regulatory requirements and accurately reflects operational activities.
- Participate and execute tasks to support the compliance and transition of QMS to MDR 2017/745 in accordance with company quality plan.
- Supports Document Management through timely review, approval and dissemination of all Quality Controlled documents.
- Interact with the design & development department, inspection department and external suppliers to resolve all internal and external NCRs including root cause investigation and implementation of corrections/corrective actions.
- Conduct all supplier control activities as per established company procedure such as New Supplier Qualification and Approval, Supplier Risk Assessment, Performance Evaluations, updating Quality Agreements.
- Work with suppliers to ensure and improve compliance. A critical part of the role includes management of non-conformities raised that are supplier focused and needs resolution through excellent management of supplier relations.
- Conduct external supplier audits to ISO 13485:2016 (this may require travelling abroad)
- Conduct internal audits utilising company audit program questionnaire and processes.
- Participate in sterilisation validation maintenance activities.
- Write technical documentation/report, audit reports, CAPAs and NCRs reports
- Write and manage engineering concession and quarantine justification requiring technical expertise in collaboration with the Design and Development Team.
- Coach and support in the writing of procedures, instructions, protocols, and other quality documents across all departments.
- Conduct weekly batch release activities.
- Conducts continual development and improvement activities of QMS processes and procedures driving lean practices throughout the team.
- Monitoring of quality KPI’s via periodic review of internal processes, especially those that affect the quality of the organization's products and provide input for Management Review.
- Support Leadership Team in implementing and maintaining all aspects of the Company QMS
Austin Fraser is committed to being an equal opportunities employer, and encourages applications from candidates regardless of sex, race, disability, age, sexual orientation, gender reassignment, religion or belief, marital status, or pregnancy and maternity status.
Due to the volume of applications received, we are unable to provide individual feedback to unsuccessful applicants.
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