- Reference: 46347
- Job Type: Permanent
- Location: Belfast City, Nationwide
- Category: Medical Devices
New position available to the BELFAST MARKET !
Leading innovative and rapidly growing Medical Technology /Medical Device organisation with operations in Ireland, Northern Ireland, EU and USA have a new position for a Quality Manager to join their growing team.
Position will report direclty to the Global Head of Quality & Reg Affairs. At a site level you will lead and manage a small site based team from Belfast and be part of the overall global team.
The Quality Manager will be responsible for implementing best practice initiatives to improve process capability, and will provide ongoing leadership within the group. As a departmental leader you are expected to be a role model in exhibiting the quality behaviours and values of the company and continuously fostering the development of others.
As Quality Manager for the Belfast Facility your responsibilities will include, but are not limited to, the following:
- Responsible for the implementation and maintenance of clauses and systems in compliance to ENISO13485:2012 including the applicable elements regional requirements, (e.g. MDD93/42, CMDCAS, 21CFR820, HSA, TGA, JPAL etc.)
- Aiding transition to the ISO13485:2016 and MDR 2017/745.
- Leadership of Quality Personnel to ensure effectiveness in the delivery of site and departmental goals, including allocation of work and project management.
- Management of document and design change control process to ensure all changes are handled within the requirements of company protocol.
- Lead training and capability development, to assure focus on problem prevention as well as detection.
- Working with existing and developing new reporting methodologies for Key Performance Indicators.
- Response for management review for all sites to ensure continuous improvement of Quality Management Systems.
- Coordinate the Risk Management program, identifying the true critical to quality procedures for each product, quarterly updates to our risk management files.
- Conduct product training, to build understanding of quality requirements in all levels of the organization through training and coaching activities.
- Execute internal audit process and lead the organization during all third party audits, notified body and regional authority.
- Execution of assigned projects (design and otherwise) within cost and schedule requirements including the company initiatives including six-sigma, lean, safety and cost reduction.
- The ongoing drive to improve quality performance by use of CAPA, Kaizen, NCE using applicable root cause analysis methodology, with a specific focus on reduction of technical support issues and customer complaint reduction.
- Work with sister-organizations to develop best practices in all aspects of Quality Management.
- Manage all identified training and development activities as required including allocation of Mindflash courses to determined timelines.
- Be available to travel nationally and internationally on requirement and to be able to function as back up to sister sites when required.
- Carry out additional duties that may be assigned to you.
- A degree in Quality Management / Engineering / Technical discipline or equivalent experience.
- Lead auditor IRCA certified.
- Risk management training to ISO14971:2012.
Skills and Competencies
- Experience of working within a regulated industry with knowledge of MDD (Medical Device Directive), ENISO13485 (Quality Management Systems), FDA, and Risk Management (ENISO14971)
- A minimum of 5 years’ experience working within a quality manager with active within a medical device environment.
- Experience working within a medical software environment a distinct advantage.
- Experience in a leadership role with people management responsibility
- Ability to work with cross-functional teams, including regulatory affairs, engineering and materials.
- Ability to multi-task and to work in a high paced environment with an awareness of continued impact on production and the plant performance.
- Organised and resourceful with excellent attention to detail and ability to get the job done
- Clear written and verbal communication skills
- Energy and self-motivation.
- The ability to focus on problem resolution in the organization.
- The ability to take responsibility for own professional development and implement new approaches to doing things. Focused on simplicity of implementation.
- An excellent record of attendance and time keeping
Core Competencies reflect the culture of the company as follows: Customer Focus, Drive for results, Adaptability, Creativity , Problem Solving, Intercompany relationships.
This is a growing innovative organisation, with a pipeline of new innovative medical technologies & medcial devices coming to the global market, seeking candidates with a flexible attitude and willingness to champion new challenges.
For a confidential discussion and more information on the role, please contact Mary Mullin on 09064 78104 and email your cv and cover note to firstname.lastname@example.org
For more information on our Recruitment and HR Services and to see a full list of our available jobs across Ireland, please visit our website www.collinsmcnicholas.ie
Follow us on LinkedIn and connect with our Recruitment Consultants to discuss the latest jobs as well as our job searching tips and videos!