Quality & Regulatory Affairs Manager
- Reference: ATR0005
- Closing Date: 31/10/2017
- Type: General Application
- Lead the QA Department to ensure continued compliance with ISO13485 and the Medical Device Directive (93/42/EEC) along with other relevant regulations e.g. REACH, cosmetics directive. The job holder will also report on performance and make recommendations for future improvements as well as liaising with Senior Management accordingly.
- Promote Continuous Improvement within the company and support the development of LEAN and Six Sigma methodologies.
- Drive improvements across the business to include the supply chain and distribution to maintain and improve product quality and process efficiency.
- A Quality professional, educated to degree level (or equivalent), with considerable quality experience (e.g.BS EN ISO13485 & BS EN ISO14000) within a medical device related environment.
- Knowledge of the Medical Device Directive 93/42/EEC and experience creating and maintaining CE technical files.
- Ideally Black Belt or minimum Green Belt Lean Six Sigma trained with experience of implementation including DMAIC, 8D, 5S, process capability, DOE.
- Lead Auditor or trained as an internal auditor.
- Experience working in the medical device or pharmaceutical industry.
- Computer literate with good working knowledge of Microsoft Word, Excel, PowerPoint.
- Champion, support and/or lead quality, Continuous Improvement, Lean or Six Sigma initiatives.
- Lead and provide direction and objectives for the QA team ensuring processes within the QMS are maintained and improvements made.
- 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.
- Support notified body audits and 3rd party audits and ensure all findings are followed up and closed out in a timely manner.
- Provide progress reports on Departmental KPIs and represent the Quality Department during Senior Management meetings in order to report status and recommend areas for improvement.
- Support the implementation of the Company Health & Safety Policy.
- 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 out.
- Manage corrective and preventive actions (CAPAs) and lead CAPA teams as necessary.
- Ensure validation of new materials or materials changes through full validation, training and monitoring.
- Lead Continuous Improvement (CI) projects or assist with Continuous Improvement initiatives and communicate progress to CI teams with regards to key KPIs including waste and customer complaints.
- Manage change control and ensure the document control system is maintained.
- 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 audit.
- Ensure good collaboration with suppliers and the follow up and closure of supplier quality issues.
- Gather VOC data and ensure complaints are fully closed out and post market surveillance data is collated, trended and reported.
- Work with all departments within the company to ensure efficient exchange of information and support is provided when necessary.
- Some travel required to suppliers, distributors and customers.
A degree of flexibility is needed and the job holder may be required to perform work not specifically referred to above and which will be appropriate to the level of the role.
Reporting to: Technical Director