Quality and Regulatory Affairs Manager
Office Based - Location Crawley
Hours - Monday to Thursday 8am to 4:45pm Friday 8am to 1pm
Salary £55,000 to £65,000
It's with great pleasure that I can share my client's requirement and support their search for an experienced Quality and Regulatory Affairs Manager.
Based in Crawley, my client specialises in the manufacture design and development of Medical Devices. They are a market leader in their specialist industry and are now looking for somebody to lead both QA and RA functions.
You will be responsible for 4 direct reports in both Quality and Regulatory departments. Reporting yourself directly into the Managing Director.
To lead both the QA and RA functions in implementing and maintaining systems to the highest standard. To drive Continuous Improvement and maintaining compliance to ISO 13485, ISO 14971, MDD and MDR. To be responsible for CE and UKCA marking of Class 1 and Class 1a medical devices.
Main duties and responsibilities;
- Promote Continuous Improvement within the company and support the development of LEAN and Six Sigma
- Drive improvements across the business to include the supply chain and distribution to maintain and improve product quality and process efficiency.
- Maintain technical documentation required to support CE and UKCA marking and liaise with distributors worldwide to maintain compliance to local regulations.
- Lead and provide direction and objectives for the QA/RA team ensuring processes within the QMS are maintained and improvements
- Maintain technical documentation including Clinical Evaluation reports, Technical Files, Risk assessments to meet regulatory requirements.
- Ensure internal audits of the Quality Management Systems are carried out to maintain continued compliance with appropriate standards and regulations and make any recommendations for improvement.
- Ensure the company is informed of any regulatory changes, assess and report the impact on the company.
- Manage notified body audits and 3rd party audits and ensure all findings are followed up and closed out in a timely
- Provide progress reports on Departmental KPls and represent the Quality Department during Senior Leadership meetings in order to report status and recommend areas for
- Support the implementation of the Company Health & Safety
- Support new product development ensuring quality plans, specifications, training and full validations are complete and ensure a smooth handover to production.
- Ensure the shop floor is fully supported to ensure manufacturing quality issues (NCRs) are dealt with and closed out in a timely manner. Ensure associated documentation is completed and follow up until actions and documentation including database records are closed
- Manage corrective and preventive actions (CAPAs) and lead CAPA teams as
- Ensure validation of new materials or materials changes through full validation, training, and monitoring.
- Support Continuous Improvement initiatives and communicate progress to Cl teams with regards to key KPls including waste and customer complaints.
- Support change control and ensure the document control system is
- Work closely with Purchasing to establish supplier quality performance criteria and monitor supplier performance, including assessing supplier's product specifications.
- Approval of suppliers through site visitation and
- Ensure good collaboration with suppliers and the follow up and closure of supplier quality
- Ensure complaints are fully closed out, reported to competent authorities as required and post market surveillance data , including proactive PMCF is collated, trended and
- Work with all departments within the company to ensure efficient exchange of information and support is provided when
- Some travel required to suppliers, distributors and customers
- Responsibility to adhere to the Company's Health and Safety policy at all times
- Operate and promote the development of quality standards and procedures taking ownership of tasks and to seek new improved ways of doing things.
Matchtech acts as an employment agency for permanent recruitment and employment business for the supply of temporary workers and is part of Gattaca Plc.
Gattaca Plc provides support services to Matchtech and may assist with processing your application.
Permanent, Full Time
- Industry Sector Other