Company Overview
At FlexMedical Solutions (FMS), we help our customers bring their ideas to life and create a healthier tomorrow, by providing contract design, development, and manufacturing services to medical device OEMs. Our main focus is on Point of Care (POC) in vitro diagnostic (IVD) tests.
Our in-house capabilities range from screen printing and laser ablation of electrodes for biosensors to final device assembly, including controlled deposition of chemistries. The company was formed in 2015 and our modern facility has recently been further expanded to a very high standard.
Based in Livingston, central Scotland, we are less than 20 minutes from Edinburgh airport and 40 minutes from Glasgow. Further growth means that we are expanding our premises, capabilities, and systems. With a mixture of UK and international clients, we are a forward-looking organisation with an exciting future.
Role Description
Reporting into the Quality Manager, as an experienced Project Quality Engineer, day to day activities will include providing support and guidance on R&D activities, through the design and development process, design transfer, and into routine manufacturing. You will be working cross-functionally with several other business areas and will be responsible for all aspects of product quality. You will already have experience of working to ISO 13485:2016 and CFR 21 Part 820.
Key Responsibilities
Reporting to the Quality Manager you will: –
- Act as quality lead on cross-functional projects to ensure the proper application of design controls.
- Support new product introduction as part of design transfer.
- Conduct investigation, bounding, documentation, review, and approval of Non-Conformances and CAPAs. Escalation of quality issues as appropriate.
- Utilise Quality Engineering principles and problem-solving skills to develop and optimise products/ processes.
- Develop, interpret, and implement appropriate process monitoring and control methods consistent with the level of process/product risk.
- Lead risk management activities and ensure consistency of approach and adherence to established operating procedures.
- Liaise directly with clients ensuring effective customer management for quality specific matters.
- Ensure ongoing compliance to ISO13485, FDA 21CFR part 820 and other regulations governing products, including providing support during internal and external audits.
- Promote a ‘Quality First’ culture whilst leading by example and offering solutions.
Knowledge, Skills, and Experience
Essential:
- Be qualified in a scientific or engineering discipline, ideally to bachelor’s level as a minimum, or have relevant, demonstrable experience instead of qualification.
- Have a competent understanding of ISO13485:2016 and CFR 21 Part 820.
- Demonstrate proven experience in supporting projects through all phases of the product development lifecycle including routine manufacture.
- Be able to understand technical challenges and interpret technical information including drawings and specifications.
- Be comfortable running complex risk assessment activities.
Desirable:
- Proven auditing skills (internal and external).
- Strong / demonstrable experience in CAPA and Non-Conformance reports.
- Process Excellence skills – Green belt would be of particular advantage.
- Competency carrying out statistical analysis.
- Previous experience in point of care, disposables manufacture.
- Experience of effectively communicating across organisations and with all levels.
Environment & Culture
FlexMedical Solutions is an evolving, scaling organisation operating in a highly regulated industry. The company is enjoying growth through success and is working on a number of leading edge projects with very exciting customers.
It is a changing environment that requires you to be very flexible and willing to learn and grow with the company. It is essential that you communicate with your colleagues and contribute actively to the company’s success. As a provider of sub-contract services, working for FlexMedical Solutions will bring a great deal of variety and excitement; initiative will be rewarded, and personal development is a given.
Eligibility to Work
FlexMedical Solutions is unable to sponsor applicants for the purpose of working in the UK. To be considered for this post, you must have an existing right to work in in the UK at time of application.