40000-45000 Per Annum
5 months ago
Location: Irvine, Scotland
Salary: Circa £40k
Quality Manager (Medical Devices)
A medical devices manufacturing company are looking to recruit a Quality Manager to join their business at a time of exciting growth for the company.
Quality Manager - The Position:
Within the position you will be responsible for the maintenance and implementation of the QMS and ISO13485 certification while guiding both business units to compliance with the MDR, along with the creation and measurement of key business quality metrics.
Quality Manager - Requirements:
- We are looking for somebody with the following:
- Degree in engineering or relevant discipline
- Good understanding of quality management process
- Strong work ethic
- Problem solving skills
- Communicate effectively with multiple levels of staff throughout the organization
- Possess strong organizational skills to manage and prioritize multiple tasks
- Successful with influencing and driving results
Quality Manager - Experience
- We are looking for a Quality Manager/Senior Quality Engineer with at least 2 years’ experience of working within a manufacturing environment.
- Must have knowledge and direct experience working with ISO 13485
- Experience of working with the FDA would also be advantageous
Quality Manager - Responsibilities:
- Maintain and further develop the quality management system certified to ISO 13485:2016
- Further establish and enhance all aspects of the Quality Management System from strategic planning to hands-on implementation on topics such as, auditing, document management, CAPA resolution.
- Drive a culture of continuous education of the Quality Management System
- 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.
- Manage the CAPA system and ensure robust corrective/preventive actions are established and effective in a timely manner
- Provide Quality guidance to product-related investigations, deviations, change controls, validation protocols, validation reports, and SOPs.
- Maintain the Technical Files for each medical device and conduct Post Market Surveillance activities.
- Participation in New Product Development Projects.
For more information please call Paul Gorton on 0161 976 3540.
LEAN Engineering Recruitment Ltd are acting as a 3rd party on behalf of our client. All applications will be held on our database for current and future positions.
We will endeavour to get back to all applicants but if you have not heard from LER within 10 working days then your application has been unsuccessful but please feel free to contact us for an update.