Job Description
Our client, a world class Medtech company based in Galway, now seeks a highly experienced Supplier Quality Manager who will work with the Global Supplier Quality Management group across all manufacturing sites in providing and maintaining a supplier base in compliance with 21 CFR Part 820, ISO 13485 and MDD.
The successful candidate will act as a SME on the supplier quality management system, providing direction to and leading teams of supplier quality engineers. In this leadership role you will generate project deliverables and timeline with specific milestone inputs from the responsible individuals within the team.
The ideal candidate will be a Quality leader with strong experience in production and process controls, problem solving and possessing effective communication skills.
Responsibilities for Global Supplier Quality Management SME:
Lead system improvement teams, applying methodologies and selecting appropriate techniques for problem solving and process improvements.
Develop of and monitoring of adherence to master plans, schedules, and elevation to stakeholders and leadership team, as appropriate.
Lead supplier engineering support and specific corporate projects and initiatives, i.e. Acquisitions, Transfers and Integrations, EU-MDR Adoption & Alignment.
Provides Regulatory Audit facing support and leadership.
Provides focused quality engineering support within new product development, operational, or system/services support.
Lead development and management of an efficient and effective supplier quality management system to Medtech and company regulations.
Directs Supplier Quality group in the management of the supplier base plus additional programs/projects from technical, manufacturing and administrative areas.
Identifies program problems and obtains solutions, such as allocation of resources or changing scope specifications.
Facilitation of supplier quality management in other areas of the organization.
Requirements for Global Supplier Quality Management SME:
Honours Bachelor’s Degree (Level 8) in Engineering, Science or Quality Assurance. Lead Quality Auditor certification and / or experience preferred.
10+ experience of Supplier Quality, with proven experience in leading and directing programmes, and teams.
3+ years people management experience, plus demonstrable leadership in identifying and driving quality improvements.
Demonstrated understanding of QSR and ISO standard requirements for material / purchasing controls, product realization, validation and CAPA is desirable.
Excellent interpersonal and communication skills with good leadership abilities.
Excellent analytical and problem-solving skills.
Please phone Larry on +353 (0)1-2302400 / larry@rftgroup.ie
The RFT Group, BioPharmaceutical Division specialise exclusively in the recruitment of scientists, engineers and executives for the biotechnology, pharmaceutical and medical device sectors. www.rftgroup.ie
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