Quality Manager for Medical Devices
Homebased – with some travel to other sites
System C is the UK’s leading health and social care software and services company and we are committed to being an employer of choice in the NHS and social care IT markets. We recognise that our success in providing effective clinical and patient management systems is wholly attributable to the commitment, dedication and expertise of our employees.
An exciting opportunity has arisen to join our Clinical Safety team. As an integral part of the team, you will have the responsibility to provide strategy, execution, and management of the company’s ISO13485 quality management system relating to compliance with applicable regulations for all products considered ‘in scope’ within the System C and Graphnet Care Alliance. This role is a full time position.
Overall responsibilities (but not limited to):
Develop and maintain compliance with all aspects of current MHRA and ISO 13485 quality system requirements including:
- Corporate quality assurance system
- Product Realisation
- Complaint handling and product analysis
- Vigilance and MDD/R reporting
- Supplier assurance contracts and auditing
- Manufacturing inspection and maintenance procedures
- Controlled documentation system
- Employee quality system training
Specific duties (but not limited to):
- Development and implementation of necessary Standard Operating Procedures (SOPs)
- Serve as the primary contact during audits by external authorities (e.g., MHRA or Notified Body)
- Develop and implement a CAPA system, including establishment of a management review process and implement a review system for Engineering Change Orders.
- Conduct employee training on the Company Quality System and MHRA/ ISO requirements.
- Conduct internal audits and lead continuous improvement activities.
- Establish procedures for monitoring product quality that is supported by the CAPA system and establish product analysis procedures for defective software and in-house failures.
- Review and quantify quality trends associated with manufactured software including complaint rates and both customer and internally identified defects and apply appropriate corrective actions resulting from trend analysis.
- Review the performance of the quality system with executive management on a periodic basis and make recommendations for necessary improvements.
- Participate as a functional member of product development teams and define and implement in-process inspection and final product test requirements ensuring all finished software meets established customer and company quality standards.
- Execute and direct quality activities and assist upper management in developing and maintaining the company quality vision and goals.
Qualifications and skills
- Thorough understanding of ISO 13485 quality system requirements including design controls.
- Demonstrated development and implementation of quality system procedures and policies and the ability to implement, execute, and maintain quality system policies and procedures.
- Ability and desire to implement and oversee continuous process improvement programmes with the skill to define problems, collect data, establish facts and draw valid conclusions
- Knowledge of Software development and advanced oral, written & computer skills.
- Can effectively elucidate quality system procedures and practices to both novices and experts.
- Effective multi-tasking skills, creative problem solver with high attention to detail and accuracy and the ability to accurately prioritise and execute with minimal direction.
- Bachelor of Science Degree (mechanical or biomedical engineering a plus).
- Minimum of 3 years in a Quality Management position with increased levels of responsibility in quality, auditing, training and ISO 13485 experience.
- Certified Quality Engineer (CQE) preferred.
Please apply in writing, sending a covering letter and CV to firstname.lastname@example.org