Salary: €60,000 - €65,000 plus benefits
Permanent full time
- Assist with the implementation of and compliance to the Quality Management program and for supporting company goals, objectives, policies, procedures, quality systems and compliance with regulatory requirements, specifically in the area of Supplier Quality
Principle Responsibilities: (essential job duties and responsibilities)
- Prepare, maintain and review supplier quality assurance procedures to ensure compliance with customer and regulatory requirements.
- Complete the supplier performance review process. Generate appropriate performance metrics, and drive resolution of issues.
- Develop and execute the global supplier audit schedule. Travel to supplier facilities to conduct audits and to enhance effectiveness and capabilities.
- May also audit third-party manufacturers to ensure due diligence of supplier and subcontractor vendor selection process Review and analyze corrective action reports (SCAR’s) to reduce and eliminate defects.
- Process and implement supplier changes through the supplier change notification process
- Support supply chain managers in the development of new suppliers or existing suppliers of new components, to improve reliability and/or reduce cost.
- Support the development of budgets, schedules, and performance standards.
- Drive continuous performance improvement and issue resolution with suppliers, engineering, and manufacturing utilizing tools such as Six Sigma DMAIC, FMEA, SPC, 8D Root Cause Analysis and Lean Manufacturing concepts.
- Ensure that suppliers and subcontractors receive engineering, manufacturing, and quality requirements.
- Lead briefings and technical meetings for internal and external representatives.
- Stay current with FDA and International requirements and industry trends in regards to regulations and expectations for industry
- Follow strict adherence to the requirements of CGMP.
- Comply with all relevant training required and adhere to relevant associated documentation.
- Actively contribute to the enhancement of compliance initiatives for areas of responsibility.
- Five years experience in a similar role
- Familiarity of working in a regulated environment, specifically medical device, FDA or ISO registered work environments.
- Strong computer skills (MS Excel, PowerPoint, Word etc).
- Experience with problem solving techniques.