Senior Quality Engineer
Our client is a rapidly growing medical devices company developing, manufacturing and marketing smart connected diagnostics and diagnostic-led care solutions.
We have recently launched an innovative medical device and technology platform, and are looking for proactive, experienced, focused and enthusiastic individuals who can make a significant contribution to the continued growth and success of our dynamic and forward-looking company.
Reporting to the Senior Quality manager, the Senior Quality Engineer shall be accountable for maintaining compliance of the Quality Management System and providing support to local departments to ensure the requirements of ISO 13485:2016 and CFR 21 Part 820 are implemented in full. The successful candidate will be a subject matter expert able to lead activities and manage other qualified personnel to achieve required business goals and drive quality improvements. The role will require significant interactions with key stakeholders and on occasion with external parties (eg suppliers, external auditors). Activities such as document/process creation, review and approval of documents, batch release and internal audits are requirements of this role.
Roles and Responsibilities
- Quality representative for one or more departments providing QA expertise, ensuring full QMS implementation, identifying opportunities for QMS improvements and leading the implementation of those improvements
- Coordination of QA activities associated with QMS changes; batch release; customer feedback (including complaint) investigations; process validation and / or supplier monitoring to meet the wider business goals.
- Organize, host and facilitate risk management related activities and ensure compliance of such activities to the applicable standards and regulations.
- Management of quality personnel
- Monitoring of quality KPI's and input to management review
- Execution of internal and supplier audits
- Support and input to external audits
- Coach and support in the writing of procedures, instructions, protocols, risk assessments and specifications
- Prepare and create documents and records for upload on to the document management system
- Review and approve change controls as Quality representative on project teams and QMS
- Knowledge and experience of working to ISO13485, FDA 21 CFR Part 820, MDSAP
- Experience of working in a relevant Quality Assurance role within medical devices or highly regulated industry
- Experience of post-launch IVD or medical device activities in a quality role
- Scientific background
- Competent IT skills in EXCEL; POWERPOINT; WORD and ability to pick up new systems (eg document management; complaint; ERP systems)
- Specific relevant experience with a high level of knowledge e.g. complaint investigation, batch review/release, process validation
- Excellent organizational skills for working on and prioritizing multiple activities
- Ability to use problem-solving tools and methodologies
- Ability to influence internal and external parties
- Qualification to degree level
- People management experience
- Knowledge and experience of MDSAP
- Trained auditor
- Continual Improvement Training (PDCA, Kaizen, Six Sigma, Lean, Value Stream Mapping)
To find out more about Real please visit www.realstaffing.com
Real Staffing, a trading division of SThree Partnership LLP is acting as an Employment Agency in relation to this vacancy| Registered office | 1st Floor, 75 King William Street, London, EC4N 7BE, United Kingdom | Partnership Number | OC387148 England and Wales