Senior Quality Engineer – Hampshire – Medical Devices
This is a brand new, challenging and exciting role that will afford you the opportunity to join a leading Medical Device Manufacturer. The Quality & Regulatory team enables innovation for our customers by collaborating with and guiding the business to achieve quality and regulatory compliance in a rapidly changing environment.
In this role, you have the opportunity to take a Team Lead role, covering the following activities:
* Collaborate with multi-disciplinary teams to proactively engineer quality and ensure compliance for raw materials, components, finished products from suppliers
* Develop and support regulatory compliance gaps at suppliers, including supplier quality system, supplier quality agreements and process development activities
* Manage additions/deletions/changes to the status of suppliers
* Ensure raw materials and components are released from suppliers according to the agreed specification and quality requirements
* Ensure that appropriate quality plans are made that include all stages of the product development life cycle
* Validate key design inputs
* Provide effective oversight of the execution of the Quality Plan, any Risk Management activities, and of all design related activities during the product lifecycle
* Perform independent technical assessment on product quality performance and post-market product quality analysis
* Lead quality related problem solving and root cause analysis during design and manufacturing
* Be responsible for ensuring that software and hardware design meets quality and compliance standards for every milestone
* Quality Monitoring spanning the entire Quality Management System (QMS), its elements, and is conducting it through the entire product lifecycle: from design, into operations, supplier controls, acceptance activities, and through post distribution surveillance
Senior Quality Engineer Experience:
* Extensive experience in Quality Engineering and CAPA processes in a medical device or regulated industry, ideally operating at Senior Level and looking to continue to take a Lead role in the Quality Systems Team
* In depth knowledge of medical device regulations MDD, MDR, and ISO 13485 and other global laws and regulations and standards including ISO14971, IEC 60601 and related particular standards.
* Working knowledge of NPD and development in a regulated environment such as Medical Devices
* Working knowledge of the application of risk management to Medical Devices
* Demonstrated knowledge of tools and statistical techniques required to perform thorough root cause analysis and develop strong investigations.
* Able to understand and analyse complex problems, which may including software and hardware design issues
* Demonstrated ability to collaborate with the business and effectively interact with and influence employees, and managers on all levels
* Strong Project Management skills
* Excellent written and verbal communication skills
* Lead auditor training to ISO13485:2016 (beneficial)
This role represents a unique opportunity to join a recognised Medical Device Manufacturer that are moving in the right direction, with a range of exciting and innovative products. This role comes with a highly competitive salary, and a host of benefits in addition to this.
If you are interested, please don’t hesitate to get in touch with Jamie at TEC Partners, as this role is unlikely to be around for long!