Quality Manager

Quality Manager

Competitive

South Wales

Days - Monday - Friday

Yolk Recruitment is excited to be working with a Medical Manufacturer who are looking for an experienced Quality Manager to join their team. As a Quality Manager, you will be responsible for managing the site Quality Management System (QMS) to ensure regulatory and customer requirements are met. You will also be responsible for monitoring and analysing critical to quality features in production to identify trends and provide early warning of potential quality issues.

This is what you'll be doing as Quality Manager:

• Manage and maintain the business management system certified to ISO 9001, ISO 13485.
• Perform internal audits to ISO 9001, 13485 and preferably ISO 14001.
• Assure ongoing compliance with quality and industry regulatory requirements.
• Perform non-routine quality and product audits of the manufacturing area and product.
• Quality monitoring and trending of production processes.
• Deliver insights and refereeing for the activities required to improve quality in the manufacturing processes.
• Ensure that all work is performed to cGMP requirements and that the production area remains in a safe and tidy condition.
• Analyse data for trending to identify areas for improvement in the quality system.
• Identify and provide quality training where necessary throughout the facility.
• Investigate customer complaints and non-conformances.
• Use problem-solving tools, to achieve documented resolution of customer complaints, technical issues and non-conformances affecting the product or processes.
• Prepare reports to communicate outcomes of quality activities to senior management.
• Support cross-functional projects and continual improvements.
• Any other duties assigned by the Quality Director.

The experience you'll bring to the team as Quality Manager:

• Degree qualified or with equivalent experience in an Engineering, Science or Technology discipline.
• Experience in a quality related field within a Medical Device design environment or equivalent regulatory controlled environment.
• Full knowledge and understanding of the quality standards ISO 9001 and ISO 13485 and their application as well as experience in the management/implementation of a quality management system.
• Internal auditor to ISO 13485 and ISO 14001 standards beneficial.
• Implementation of corrective action programs.
• Product or industry-specific experience.
• Strong computer skills.
• Quality tools, concepts and methodologies for Quality Assurance.
• Applicable regulatory requirements including Medical Device Directive 93/42/EEC & UK MDR 2002.
• Continuous improvement techniques.
• Experience managing/leading a team.

And this is what you'll get in return:

• Competitive salary based on experience.
• Comprehensive benefits package.
• Opportunity to work with cutting-edge technology in a dynamic team.

If you feel you have the skills, experience and passion to be successful in this Quality Manager role apply now

*Please note, whilst we do our best to contact all candidates, due to the high number of applications we receive we cannot guarantee this for every role. If you have not heard anything from us within 7 days of applying - then unfortunately you have been unsuccessful. Please keep an eye on our website for more opportunities.