A leading manufacturer of medical devices is seeking a dynamic Quality Manager in order to develop, organise and manage the company's quality system and quality team.
The job role is best suited to a very motivated, well organised person with management experience and excellent communication skills, for both internal and external communication. You will need to be driven to make substantive improvement to the quality department.
Quality Manager Responsibilities:
- Act as a change agent for the rapid evolution from a quality control to a quality assurance structure.
- The drive and energy to lead transformative change in the way we approach quality building it in to processes and design.
- To build and develop a new quality team focused on identification of issues and root causes, addressing them and delivering permanent improvement. Coaching them to continually improve themselves and the business.
- Manage and facilitate corrective and preventive actions required for QHSE, ensuring all product related issues, customer complaints/Accidents, Incidents etc. driving through to closure.
- Establish automated reporting on performance against KPI's and regulatory reporting for QHSE.
- Administer and support, including regulatory reporting the established group policy for the FDA and EHS certifications as well as applicable statutory reporting for the KWF site e.g. FDA, HSE, the Environment Agency etc.
- Take the lead in any complex investigations as appropriate.
- Ability to analyse data and information, both numerical and anecdotal to determine plan of action and carry it out.
- As the company representative implement and maintain the company's Business Management Systems ensuring compliance to ISO9001, 14001, OHSAS 180001/ISO 45001 and ISO 13485 and FDA QSR requirements as appropriate.
- Assist in new product introduction from design stage through to production.
Quality Manager experience and abilities required:
- Experienced Quality Manager ideally with a electro-mechanical medical device industry background. Other electro-mechanical industry backgrounds will be considered.
- Strong leadership and coaching skills
- Experience in implementation and maintenance of Business Management Systems ensuring compliance to ISO9001/14001
- New product introduction
- H&S, Environmental and Quality Legal and Regulatory Knowledge
- Knowledge of quality systems related to medical devices - FDA/ISO 13485 or other highly regulated industry is desirable although not essential
- Knowledge of EH&S systems and legal requirements
- Strong IT skills
- Excellent interpersonal skills at all business levels
- Good presentation/ communication skills
- Great prioritising and managing high workload ability
- Analysing and interpreting data and good reporting skills
- NEBOSH is desirable
- Strong engineering (ideally electro-mechanical) background and education
Please apply as soon as possible to this highly desirable Quality Manager role with a leading medical device manufacturer.