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Senior Supplier Quality Engineer
2 months ago
Agilent Technologies is seeking a highly skilled Senior Supplier Quality Engineer to join our team. As a key member of our quality assurance team, you will be responsible for ensuring compliance with various regulations and standards, leading supplier quality compliance projects, and developing partner quality agreements.
Key Responsibilities- Regulatory Compliance: Ensure compliance with 21 CFR part 820, ISO 13485:2016, IVDR, and MDSAP regulations, and lead supplier quality compliance projects to address compliance gaps.
- Supplier Quality Assurance: Develop and implement supplier quality agreements, manage high-visibility SCARs, and conduct key supplier audits.
- Process Improvement: Lead projects to improve supplier quality processes, increase efficiency, and address compliance gaps.
- Global Process Ownership: Own supplier quality processes, including supplier selection, evaluation, and re-evaluation, SCAR process, and supplier monitoring.
- Communication and Collaboration: Work with cross-functional stakeholders, including regulatory affairs, quality systems, and procurement teams, to ensure effective communication and collaboration.
- Leadership and Project Management: Lead internal CAPAs related to supplier quality, high-visibility SCARs, and key supplier audits, and guide procurement on ASL maintenance and supplier qualifications.
- Technical Expertise: Provide technical guidance to international Agilent sites on local and regional supplier quality execution and maintenance, and support internal and external audits.
- Education: Bachelor's degree in Engineering, Pharma, Biomedical, Health Sciences, or equivalent; Master's degree preferred.
- Experience: Minimum 5 years of related experience in supplier quality and/or product quality or related field.
- Skills: Excellent knowledge of 21 CFR part 820, ISO 13485:2016, IVDR, and MDSAP regulations; certified ISO13485:2016 lead auditor credentials preferred or completion of a 3rd-party certification training for lead auditor.
- Soft Skills: Strong organizational, written, and verbal communication skills; ability to prioritize tasks effectively in a deadline-driven environment; excellent leadership and project management skills.
- Competitive Compensation and Benefits: We offer a competitive compensation and benefits package, including a comprehensive health insurance plan, retirement savings plan, and paid time off.
- Career Development Opportunities: Agilent Technologies is committed to the growth and development of our employees, offering opportunities for career advancement and professional growth.
- Work-Life Balance: We encourage a healthy work-life balance, offering flexible work arrangements and a supportive work environment.
