Principal Supplier Quality Engineer
Principal Supplier Quality Engineer
Our client a medical device company are currently looking for a Principal Supplier Quality Engineer for their Galway site on a permanent basis.
- Develops, establishes and maintains quality engineering methodologies, systems, and practices which meet customer, and regulatory requirements.
- Provides direction to and leads a team of supplier quality engineers.
- Act as a SME on the supplier quality system.
- Serves as a Quality representative to improve awareness, visibility, and communication on quality initiatives to support departmental, functional, site, divisional and corporate quality goals and priorities.
- Provides focused quality engineering support within new product development, operational, or system/services support.
- Operates as part of a global supplier quality team collaborating across the network of sites in providing and maintaining a supplier base to service a world class medical device business.
- Exercises a high degree of technical autonomy through developing and managing an efficient and effective supplier quality management system which complies with all current medical devices standards such as 21 CFR Part 820, ISO 13485 and MDD.
- Directs the work of employees assigned to the management of the supplier base plus additional programs/projects from technical, manufacturing and administrative areas.
- Provides guidance and leadership in the execution of the all aspects of the supplier management system:- SCARs, SCIA, Material Qualification, Supplier Assessment, Calibre Programme….
- Identifies program problems and obtains solutions, such as allocation of resources or changing scope specifications.
- To lead system improvement teams using a variety of different methodologies and selecting appropriate techniques for problem solving and process improvements.
- Has overall responsibility for generating project deliverables and timeline with specific milestone inputs from the responsible individuals within the team.
- Develop of and monitoring of adherence to master plans, schedules, and elevation to stakeholders and leadership team, as appropriate.
- Facilitation of supplier quality management in other areas of the organization.
- May provide dedicated supplier engineering support and leadership to specific corporate projects and initiatives, i.e. EU-MDR Adoption & Alignment
- Demonstrates a high level of initiative through continuous questioning of current practices.
- Strong leader with the ability to identify and drive quality improvements.
- Provides Regulatory Audit facing support and leadership
- Excellent interpersonal and communication skills with an ability to influence others
- A level of travel will be expected in the role
- NFQ Level 8 qualification in a relevant discipline with minimum 8-10 years' experience in a relevant area.
- Good technical capabilities, communication skills, teamwork abilities and initiative.
- Experience in leading and directing programmes and teams
- Proven ability to work well as part of a team & on own with minimum supervision.
- People Management experience is essential
- Travel will be part of this role
For further information on this Principal Supplier Quality Engineer role in Galway please contact Clara Burke on 086 8168273/ email@example.com
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