Our client, a leading company in software for medical devices requires an experienced Quality Manager to lead the US operations. This role is based in New York City with travel to other cities required once a month. The successful candidate must be a SME in Quality Systems, regulatory affairs and auditing. This role is ideally positioned for further advancement within the organisation.
The Quality Manager will be responsible for implementing best practice initiatives to improve process capability, and will provide ongoing leadership across three locations. 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.
- 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.)
- 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.
- Develop reporting methodologies for Key Performance Indicators across all sites.
- Response for quarterly management review for all sites to ensure continuous improvement of Quality Management Systems.
- Participate in our 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.
- 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.
- Carry out additional duties that may be assigned to you
Education, Experience and Skills:
- A degree in Quality Management / Engineering / Technical discipline or equivalent experience.
- EN13485:2013 Lead auditor IRCA certified.
- Risk management training to ISO14971:2012
- Experience of working within a regulated industry with knowledge of MDD (Medical Device Directive), ENISO13485 (Quality Management Systems), FDA, and Risk Management (ENISO14971)
- 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
Please Note: Must be available to travel nationally and internationally on requirement and to be able to function as back up to sister sites when required.
For further information on this Quality Manager role in New York please contact Cliona O'Malley on 091730022 / firstname.lastname@example.org
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