Quality Engineer

Job title : Quality Engineer
Location :
Job type : Permanent
Salary : Up to €100000 per annum
Contact name : John Spring
Contact number : +41 (0) 44 5803 717
Contact email : john.spring@seclifesciences.com
Principal Quality Engineer - Medical Devices (Remote Role)

This position offers a great opportunity to work with a well-funded medical device company who are approaching late clinical phase and moving into commercialisation. They are a company SEC Life Sciences have partnered with for several years and have seen massive growth and success with a great product pipeline. You will be a crucial team member in Europe, providing significant quality, validation and risk management knowledge to ensure a smooth transition into the market for a very exciting catheter based medical device product, which will have a great impact on millions of people all over the planet.

Salary & Benefits:

Up to €100k, full details on request

Role and responsibilities:

*Overall responsibility for QE (Quality Engineering) and DA (Design Assurance) of the company's medical device products in development.
*Act as the subject matter expert for all QA and QC activities involved in design, manufacture, testing and release of products, ensuring compliance with ISO 13495, ISO 14971 and MDD/MDR guidelines.
*Leadership in the development and the implementation of all processes and documents relating to inspections and compliance and ensure global quality standards are maintained at all times
*Play a key role in successfully transitioning from clinical to commercial manufacturing
*Manage all quality engineering activities at external partners (CMOs) including validation and continuous improvement
*Management of root cause analysis investigations, CAPA and nonconformance management
*Work closely with Operations and R&D for audits and risk management - strong 14971 knowledge required
*Manage and promote continuous improvement initiatives for global roll out

Requires skills and qualifications:

*At least 10 years' experience in design/manufacturing quality engineering in the medical device industry (catheter experience preferred)
*Excellent working knowledge of compliance for FDA 21CFR820, ISO13485, 14971 and MDD/MDR guidelines
*Strong operational QA knowledge - CAPA, deviation, audit, root cause investigation
*Good supplier quality management experience, working with CMOs
*Successful track record in seeing medical device products through development into the commercial manufacturing phase is preferred
*Excellent communication skills and the ability to work autonomously 13485 & 14971 and other applicable regulatory requirements.

This is a great role; it is working with a very well funded and highly regarded medical device company with a product range about to make a huge impact in their field. The role will offer a great progression opportunity for an ambitious QA professional looking to bring products to market and work internationally. This is a remote role, requiring around 25% travel in Europe.

To apply for this position and put yourself under immediate consideration, send your CV to john.spring@seclifesciences.com or call +44 (0) 207 255 6650