With over 30 years’ experience, GVS Group is one of the world’s leading manufacturers of filters for application in the Medical, Laboratory, Automotive, Appliance, Safety and Building Filtration sectors. The origins of GVS initially focused on medical filters for blood and IV solutions. Today GVS provides a wide range of innovative products, including standard and custom devices for laboratory filtration, anaesthesia, intensive therapy, and respiratory medicine.
The corporate headquarters of the GVS Group is located in Italy and has business units across Argentina, Brazil, China, India, Italy, Japan, Malaysia, Mexico, New Zealand, Romania, South Korea, Thailand, Russia, Turkey, UK, USA, and Vietnam.
Key Responsibilities & Activities
* Responsibility for development, implementation and continued improvement of the quality management system and regulatory documentation.
* Ensure a robust supply chain is in place to support product conformity.
* Development and maintenance of Technical Documentation for regulatory purposes.
* Managing the internal, supplier and 3rd party audit programmes.
* Liaison with external bodies, customers and suppliers.
* The UK Quality & Regulatory Manager is the appointed Management Representative.
* Responsible for working within Health, Safety and Environmental standards and procedures.
* Aptitude for team work and results orientation.
* Aptitude and ability to promote continuous improvement in a busy manufacturing environment.
* Experienced in statistical analysis techniques and application.
Job Qualifications, Skills & Attitudes
* Ability to plan and organise work load according to priority, business needs and strict deadlines.
* Very good verbal and written communication skills.
* Attention to details and excellent visual awareness.
* Ability to communicate effectively with different stakeholder groups on site.
* Ability to present data and information to senior management.
* Experience of multi-disciplined management system incorporating ISO 9001, ISO 13485, ISO 14001, ISO 45001 & ISO 50001.
* Experience of managing a multi-functional quality and regulatory team.
* Experienced in hosting notified body, and customer audits.
* Experienced internal and supplier auditor.
* Experience of regulatory processes including MDD 93/42/EEC, MDR 2017/745, CGMP as detailed in 21 CFR 820, NIOSH 42 CFR part 84 and PPE Directive 2016/425.
* Risk Management according to ISO 14971.
* Minimum 5 years’ experience in a Quality and Regulatory role.
Job Types: Full-time, Permanent
Benefits:
* Company pension
* Free parking
* On-site parking
* Sick pay
Schedule:
* Monday to Friday
* No weekends
Work Location: In person
Application deadline: 15/11/2024
#J-18808-Ljbffr