SPD Swiss Precision Diagnostics GmbH (SPD) is a world leader in the research, design and supply of advanced consumer diagnostic products. SPD was formed in 2007 as a joint venture between Procter & Gamble (P&G) and Alere (now Abbott) and our brands, such as Clearblue, are recognised the world over as providing accurate home pregnancy and fertility monitoring tests.
We are looking for a Training Specialist to join our Quality team, reporting directly into the Quality System Manager. The role works within an In-Vitro Diagnostic Quality Management System (QMS) and complies to the requirements:
- ISO 13485
- Council Directive 98/79/EC
- In-Vitro Diagnostic Medical Device Regulation 2017/746
- US FDA 21 CFR Part 820
- Other worldwide regulatory and compliance standards
This role has accountability for the management of SPD s Training Process and administration of the Electronic Document Management System (EDMS) and Quality Management System (QMS) (currently ensur). Accountability includes training coordination of Quality Management System, Business Compliance and Health and Safety.
This role will be permanent, full-time and based at our Innovation Centre in Bedford, UK on a hybrid working pattern.
- Maintain compliance to ISO 13485, IVDR, IVDD, FDA, SPD requirements
- Coordination of Business and Legal/Compliance trainings
- Management of QMS training
- Deliver and manage key deliverable for Training Management
- Maintain business process to manage training for Quality Management System, Business Compliance and Health and Safety
- Accountable for monthly KPIs within team & across the business
- Monitoring, management & escalation of training related issues
- Create, deliver and schedule training on the Mandatory Training requirements, including annual refresher training
- Provide support to subject matter experts with creation of training materials, delivery and scheduling of training
- Training delivery for new starters, Electronic Document Management System (EDMS) and Quality Management System (QMS)
- May be required to travel several times a year to our Head Office in Geneva
We re looking for someone who has:
- 3+ years experience of managing training or equivalent and working within a quality, human resources or compliance function, ideally within a regulated environment
- Working knowledge of ISO 13485:2016 and US FDA 21 CFR 820
- Excellent communication skills
- Excellent project management skills
- Ability to solve problems and execute solutions to problems/issues identified
- Self-motivated and able to plan and manage own workload
- Ideally undertaken a Train the Trainer programme and have a qualification or experience of delivering training
- Ideally would have some knowledge and/or experience in the following: -
- Medical Device Single Audit Program (MDSAP)
We can offer you:
- 25 days paid annual leave plus bank holidays.
- Bonus scheme available to all employees.
- Company pension scheme including employer s contribution.
- Private Medical Insurance package with additional medical cash plan scheme.
- Enhanced maternity and paternity pay.
- Company supported employee Health & Wellbeing programme.
- Life assurance.
- Free parking including free electrical car charging points & disabled parking facilities.
- Beautiful parkland setting with excellent transportation links to Cambridge, Milton Keynes and London (road & rail).
If you require any reasonable adjustments to support you, at any stage during the application process, just let us know how we can help.
We are an equal opportunity employer and value diversity. We do not discriminate on the basis of race, religion, colour, national origin, gender, sexual orientation, age, marital status or disability status.