Quality Systems Specialist
Elstree, Hertfordshire
Full time permanent position - competitive salary and good company benefits

Are you seeking to develop your career with a global medical device company who develop innovative products and services that ultimately improve the lives of patients? We are looking for a skilled professional with quality system regulations experience to develop and support the quality management system (QMS).

Main purpose of role
Primarily responsible for the development of the quality management system in accordance with relevant regulatory requirements for medical devices. Oversee, support, and ensure that an effective and efficient quality management system is built and maintained. Responsibility for ensuring that all applicable quality system regulations are met in order to receive regulatory clearance/certification.

Key tasks
 Supports QMS compliance with the appropriate internal and external regulatory requirements (including but not limited to Site, Division, Corporate, FDA, ISO, MDD, and individual country requirements).
 Contribute to the development of optimum future state of QMS for business needs.
 Identify improvements and inputs into the quality planning process.
 Oversee and execute development and/or modification of the QMS and internal audit management program.
 Support Management Review and Quality Planning Review and related forums.
 Assess and quantify requirements for QMS requirements to optimize structure.
 Drive GMP and GDP within Quality organization.
 Identify and implement improvement opportunities to increase the efficiency and effectiveness of the QMS.
 Develop and deliver training for QMS areas of expertise.
 Contribute to the development, maintenance, and improvements of policies and procedures.
 Implement best-in-class practices and benchmark against industry leaders and regulatory requirements.
 Liaise and communicate with notified bodies to manage certification changes.
 Ensure QMS reflects actual activities, business needs and supports NPD requirements.
 Engage in relevant QMS IS discussions.
 Key contributor to QMS business process(as) and understand IS system support requirements.
 Support internal and external quality system audits.
 Understands system integration.
 Support IS change control assessment and approval.

Qualifications, skills and desirable experience
 BSc in Engineering, Science, or related.
 Minimum 3 years professional experience in the Medical Device Industry or equivalent preferred
 Experience in regulated environment and interaction with regulatory agencies required.
 Thorough knowledge and understanding of US and International Medical Device Regulations.
 Strong knowledge of Quality Systems (CAPA, audits, Management Review, Quality Planning, etc.)
 Strong communication, project management and influencing skills.
 Ability to plan, organize, and implement multiple concurrent tasks.

Our client is a career destination for engaged, passionate and talented people who are driven to seek the innovation, growth and opportunity. If you are keen to explore opportunities to develop your career then please apply for this position without delay.

Gi Group Pharmaceuticals provides a tailored Account Managed Service and dedicated Pharmaceutical recruitment team and partners with many different Pharmaceutical and Biotechnology clients throughout the globe and the United Kingdom.

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