Quality Manager

Job Description

The Quality Manager will be developing and managing the companys Quality Management System (QMS) in compliance with the requirements of ISO 13485 and MDSAP, along with the creation and measurement of key business quality metrics. You will be promoting thebest quality practice in all areas of the company and developing individual members of the quality department by driving a culture of continuous education of the Quality Management System.Client DetailsThe client is a successful medical device manufacturer based in Blackburn.DescriptionThe Quality Manager will work in Blackburn and be responsible for:

• Strategic planning, management, and implementation of the QMS and its sub-systems and processes and ensuring that its development meets business and regulatory needs.
• Managing members of your Quality team, their output and ensuring their continued training & development.
• Ensure effective and compliant release of product from process to process (Quality Control from Goods Receipt to Final Product Release) and from Mi3 to Customer including providing sterility assurance where applicable.
• Ensure that audit capability is developed and maintained as required by business needs and perform internal and external audits as required by the relevant schedules/subject matter expert and take the lead in hosting customer audits.
• Ensure that the complaints and non-conformance systems, and CAPA, are managed effectively and to timely conclusion.
• Implement a "Problem Solving" approach to Quality issues that will drive sustainable Root Cause and Corrective Action.
• Drive continuous improvement across the quality function, including a focus on reducing customer complaints.
• Use the analysis of information received through customer complaints, non-conformance reports, audit reports, CAPA and other relevant quality data, to make conclusions and drive actions for improvements and compliance.
• Ensure that no changes can be made without the proper review, documentation, and approvals.
• Deliver and plan/propose training in QMS topics to all levels of the business and support all staff inductions.
• Day to day support of manufacturing to provide a timely escalation and effective resolution of quality related issues.
• Manage quality related improvement projects.
• Analysis of all information received through the monitoring of information received from customer complaints, non-conformance reports, audit reports and CAPAs.
• Participation in New Product Development Projects and Technical Transfers.
• Support all staff inductions with a QMS introduction session as appropriate to their role.
• Support or work closely with other managers to conduct investigation and disciplinary/capability processes, recruitment, project delivery and staff training & development.

ProfileThe successful Quality Manager will have:

• Bachelor level degree or equivalent in a relevant Quality Management, Engineering or Science discipline.
• Minimum of 3 years experience within a manufacturing and production based medical devices business regulated to ISO 13485 in a quality role, with good, all-round knowledge of medical device quality systems.
• Demonstrable experience in quality engineering field / topics such as process control, error proofing, failure investigation and root cause analysis, CAPA, data collection and analysis, batch records, in-process testing/checks, CTQs, defect classifications,visual standards, GR&R, change management, and the application of statistics.
• Successful with influencing and driving results.
• Ability to prioritise and make decisions, whist showing good problem-solving ability.
• Positive attitude toward change and contribution to new ideas/ways of working.
• Demonstrable understanding of ISO 13485 and its practical application to a medical devices business.
• High levels of vigilance with rigorous attention to detail.
• Ability to develop working relationships with both internal and external customers.
• Knowledge of Good Laboratory Practice (cGLP) and experience of the requirements of test method development and validation.
• Understanding of additional relevant regulatory standards, including MDSAP.
• Experience of leading projects / project management having led a quality based multi-disciplinary project to successful conclusion.
• Prior experience in production equipment IQOQ, process development and process validations, new product development or production roles.
• Ability to lead cross functional projects to timely and effective conclusion.
• Previous experience of Good Manufacturing Practice (cGMP).
• Experience of planning, executing, and reporting internal, external audits and hosting auditing authority audits.
• Formally trained in process excellence tools such as Six Sigma, would be an advantage.
• Formally trained as an Internal or Lead Auditor for ISO 13485 would be an advantage.

Job OfferThe Quality Manager will be offered a competitive salary and join a successful medical device manufacturer.