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- Take the quality lead role in working with suppliers on existing process improvements to develop supplier’s processes, process validations and ensure the necessary process controls and documentation.
- Partner with Supplier Quality Auditing Team and Strategic Sourcing participating on pre and post audit activities and addressing audit non conformities initiated as results of supplier’s audits. You will drive supplier improvement activities and to eliminate product quality issues and compliance gaps at the supplier base.
- Lead quality issues with suppliers; work with internal customers to ensure internal containment and corrections/corrective actions are implemented. Lead effective containment and corrections/corrective actions with suppliers.
- Conduct trend analysis on key performance metrics related to supplier’s non conformities as results of audits, complaints and receiving inspections. Present metrics to Global Supplier Quality Management Team and internal business partners and evaluate further actions as required to deliver measurable improvement in performance of suppliers.
- Lead, track and monitor Supplier Change Requests by working with internal business partners on the decisions to accept and approve the requested change. Ensure appropriate communication with the supplier and lead all deliverables from the supplier as a result of the requested change
- Ensure Regulatory compliance in the area of responsibility to GMP of all medical devices regulatory agencies and participate in external audits.
- Lead and own the control of quality content of the Approved Supplier List, support SQM partners and Strategic Sourcing in the supplier approval and add / deletion process.
- Own global supplier quality metrics and input data for internal and supplier scorecards and participate during business reviews (internal & supplier). This includes the management and maintenance of supplier information files.
- Partner with SQM functions and Strategic Sourcing on the developments and approval quality assurance agreements with suppliers.
- All other duties as assigned.
Professional Requirements – Required:
- Bachelor’s Degree in Engineering or Science fields
- Minimum of 7 years’ experience in manufacturing environment.
- Good knowledge with GMP, ISO 13485, 21 CFR Part 820 standards
- Working knowledge of FMEA, Validation Programs and SPC processes in a highly regulated environment
- Good knowledge of lean tools and concepts. Demonstrated the ability to apply lean concepts throughout a manufacturing operation to improve quality
- Demonstrated working knowledge to influence positively the trend of the relevant supplier quality metrics.
- Strong analytical and problem solving capabilities with the ability to draw insights from data quickly and to define executable actions
- Ability to plan, organize and implement multiple concurrent tasks
- Strong communication skills. Must demonstrate the ability to communicate up/down and across different levels of the organization.
- Demonstrated ability to work in cross-functional team environments
- Willing to travel in support of business needs to different geographical locations.
Professional Requirements – Desirable:
- Preferred industries are aviation, aerospace, automotive and defense
- A working knowledge of the Supplier NADCAP Accreditation would be desirable, with particular reference to Special Process (SP) Accreditation
- A working knowledge of Airbus SQIP process or industry equivalent
- Lead Quality Auditor Qualification either in AS 9100 or ISO13485,CFR820 or comparable industry standards and regulatory requirements
- ASQ CQE/CQM/PE certification
- Strong project management capabilities with the capacity to leverage and apply knowledge
- Must demonstrate outstanding collaboration and communication skills.
- Highly motivated and able to build close relationships internally and externally.
- Demonstrated ability for conflict resolution and constructive competence
- Must demonstrate multitasking skills as this individual will be responsible for multiple tasks at the same time.
- The individual should enjoy working in a dynamic and results oriented team environment focusing on quality, compliance and customer satisfaction.
- Up to 10%
For further Information on this role, please contact John on 021 4911065 or email firstname.lastname@example.org
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