Full-time
Salary dependent on experience
Permanent
About the Client
Our client is a leading supplier of home pregnancy and fertility/ovulation tests. They are on a mission to empower women on their reproductive journey by offering innovative and reliable products.
About the Role
As a Senior Quality Innovation Engineer, you will be responsible for quality management processes and providing input for software design and development.
Responsibilities include:
QMS
- Maintaining awareness of changes to regulations, standards and directives that affect the QMS specifically in regard to innovation and assisting with programmes to integrate new requirements into the QMS.
- Managing and monitoring QMS Key Performance Indicators (KPIs) in relation to innovation.
- Supporting Document Management through review, approval and improvement including key project documentation.
- Providing support for external audit activities.
- Championing and identifying improvements across the business in conjunction with stakeholders including innovation management systems.
- Performing other appropriate unspecific duties related to the maintenance of the QMS as directed by the Quality Systems Manager.
- Owning and leading the Risk Management process.
Innovation
- Leading compliance for innovation and the implementation of existing products in new markets.
- Identifying key technical challenges and offering recommendations.
- Participating in risk analysis.
- Supporting the improvement and maintenance of the organisation’s design control processes including design lifecycle.
- Supporting the creation of project documentation to maintain compliance.
- Contributing, where applicable, to technical reviews of designs, documentation and test procedures and any other deliverables.
- Identifying any discrepancies in project compliance, addressing them through appropriate channels whilst supporting the implementation of corrective actions alongside the project teams.
- Assisting with the implementation of new Design Control tools and their integration in the appropriate quality procedures.
- Ensuring compliant onboarding of all companies where devices are third party sourced.
General
- Being a dynamic team player who can work effectively and proactively on cross functional teams assisting with ensuring that the client maintains continued compliance.
- Being self-motivated and working independently with all R&D project teams including project leaders and technical specialists.
Requirements:
Essential:
- Degree or equivalent or 3+ years’ experience of working within a medical device environment.
- Knowledge of ISO 13485:2016 and US FDA 21 CFR 820.
- Experience of design and development in the medical devices industry.
- A passion for quality.
- Excellent communication skills.
- An ability to build strong working relationships.
- Be self-motivated and able to plan and manage own workload.
Preferred:
Some knowledge/experience in the following:
- EU IVD Directive 98/79/EC or EU MDD Directive 93/42/EEC.
- Medical Device Regulation 2017/745 or In Vitro Diagnostic Regulation 2017/746.
- Medical Device Single Audit Program (MDSAP).
- Member of the Chartered Quality Institute.
- ISO 62304 Medical device software — Software life cycle processes.
- BS EN ISO 14971:2019 Medical devices. Application of risk management to medical devices.
- Knowledge or experience of software including the development of applications using Microsoft technologies.
- Ability to understand & learn new software development, processes, languages, tools and systems.
Desired Personal Attributes:
- Takes ownership and accountability
- Focusses on priorities and overcomes challenges
- Makes timely and effective decisions
- Drives compliance as a competitive advantage
- Builds trust and respect in relationships
- Is inclusive and collaborated to deliver results
- Communicates persuasively to gain commitment
- Understands and adapts to their audience