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.
We focus on the disposable component of diagnostic tests and have significant expertise with point of care (POC) in vitro diagnostics (IVD). We provide full assay development services and have impressive in-house manufacturing capabilities, ranging from screen printing and laser ablation of electrodes for biosensors to final device assembly, including the formulation and deposition of chemistries.
Our modern facilities are based in Livingston, central Scotland, less than 20 minutes from Edinburgh and 40 minutes from Glasgow. With a healthy mixture of UK and international clients, we are a forward-looking organisation with an exciting future.
Role Description
We are seeking a highly motivated and experienced Quality Engineer to join our team for a fixed term position to cover a period of maternity leave.
Reporting to the Senior Quality Engineer, day to day activities will include providing support and guidance of product and process Design & Development, and Validation & Verification activities. Cross-departmental communication and collaboration skills are essential to arrive at compliant solutions in an efficient manner. Additionally, the post holder will support/own Non-Conformance/CAPA investigations and assist during various audits.
The role requires strong experience of working to and interpreting ISO 13485:2016 and CFR 21 Part 820 to deploy creative solutions.
Key Responsibilities
- Provide quality oversight for design controls and risk management activities.
- Review and approval of equipment qualification and process validations (IQ/OQ/PQ) to meet regulatory and business requirements.
- Assist Senior Quality Engineer in the maintenance of the electronic Quality Management System (eQMS), ensuring accurate documentation and adherence to standards and documented procedures.
- Review and approve quality documentation, including but not limited to validation protocols/reports, change controls, and non-conformance reports.
- Engage clients directly as and when appropriate regarding quality matters.
- Provide support for audits and inspections by regulatory agencies, notified bodies, clients and internal audits.
- Support colleagues and occasionally own planned deviations, Non-Conformance and CAPA investigations when appropriate.
Knowledge and Experience required
Essential
- Qualified in a scientific or engineering discipline, ideally to degree level, and with proven medical device industry experience (in lieu of academic qualification, we will consider candidates with significant experience in the medical device industry).
- Extensive knowledge and experience of equipment and process validation (IQ/OQ/PQ) principles.
- High proficiency with electronic Quality Management Systems (eQMS).
- Understanding of design controls and the product development lifecycle.
- Familiarity with relevant regulatory standards (e.g., ISO 13485, FDA regulations).
- Excellent problem-solving skills.
- Excellent written and verbal communication skill.
- Demonstrable proactive approach to work.
- Detail-oriented.
Desirable
- Experience of using Dot Compliance.
- Certified internal auditor.
- Process Excellence skills (Green belt)
- Competent at statistical analysis.
- Software validation experience.
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 some 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 to the company’s success whilst demonstrating the company’s iCARE values namely Innovation, Community, Accountability, Respect and Excellence.
As a provider of sub-contract services, working for FlexMedical Solutions will bring a lot of variety and excitement. Initiative will be rewarded, and personal development is a given.