At a Glance
- Tasks: Manage change control activities and improve quality systems in a regulated environment.
- Company: Leading international manufacturer with a focus on quality and compliance.
- Benefits: Full-time role with potential for remote work after training and competitive salary.
- Other info: Dynamic role with opportunities for continuous improvement and career growth.
- Why this job: Make a real impact in a global organisation while enhancing your quality management skills.
- Qualifications: Degree in Science or Engineering and experience in Quality within regulated industries.
The predicted salary is between 50000 - 55000 £ per year.
Are you an experienced Quality professional with a passion for driving change, maintaining compliance, and improving quality systems? We're recruiting on behalf of a leading international manufacturer for a Change Control & Quality Specialist to join their European Quality team on a 6 month Temporary basis. This is an exciting opportunity to play a key role in managing change control activities across Europe while supporting continuous improvement initiatives within a highly regulated environment.
The Role
Reporting to the European Head of Quality, you will be responsible for overseeing the European Change Control programme, ensuring quality processes remain compliant with GMP and regulatory requirements. You'll work collaboratively with teams across Europe and globally to deliver successful change initiatives and maintain an audit-ready quality management system.
Key Responsibilities
- Lead and manage the European Change Control programme for temporary and permanent changes.
- Review change requests, assess business impact, and ensure compliance with GMP and applicable regulations.
- Coordinate stakeholders throughout the change control process.
- Monitor progress of change actions and ensure completion within agreed deadlines.
- Produce KPI reports and analyse change control performance.
- Identify opportunities to improve quality systems and change management processes.
- Deliver training, coaching and guidance on Change Control procedures.
- Maintain audit readiness and support internal and external audits.
- Support quality investigations, CAPA activities and continuous improvement initiatives.
- Assist in the development and maintenance of the Quality Management System (QMS).
- Ensure documentation, records and quality files are accurately maintained.
About You
We're looking for someone who has:
- A degree in Science, Engineering or a related discipline.
- At least three years' experience within a Quality or Technical function.
- Experience working within a regulated industry such as Pharmaceuticals, Medical Devices or FMCG.
- Strong knowledge of GMP and Quality Management Systems.
- Experience managing change control processes and implementing quality improvements.
- Knowledge of ISO 13485, ISO 22716, MDD and MDR.
- Experience supporting audits and regulatory inspections.
- Excellent communication and stakeholder management skills.
- Strong analytical skills with experience producing KPIs and trend analysis.
- A proactive approach with excellent attention to detail and a continuous improvement mindset.
You will be working 37 hours week Monday to Friday based between 2 sites and there may be the opportunity to work 1 day at home once full training is complete.
If you're an experienced Quality professional looking to take the next step in your career and make a real impact within a global organisation, we'd love to hear from you.
Change Control & Quality Specialist in London employer: New Appointments Group
New Appointments Group is an excellent employer for those seeking to make a meaningful impact in the field of electronics engineering. Located in the vibrant city of Canterbury, we offer a competitive salary and a range of benefits, all within a collaborative and inclusive work culture that prioritises employee growth and development. Join us to be part of a team dedicated to innovation and quality in advanced electro-optic systems.
