Quality Assurance Specialist
2 weeks ago
Agilent Technologies, a leading provider of life science, diagnostic, and applied market solutions, is seeking a Senior Supplier Quality Engineer to join our team in Denmark-Glostrup.
The ideal candidate will have expertise in supplier quality and process improvement, with excellent knowledge of regulations such as 21 CFR part 820, ISO 13485:2016, IVDR, and MDSAP. The role involves ensuring compliance, leading projects, developing quality agreements, managing high-visibility SCARs, and conducting key supplier audits.
Main Responsibilities:
- Lead projects to improve supplier quality processes, addressing compliance gaps and improving efficiency.
- Develop and compile quality agreements for business expansion with partners, including resellers, distributors, and economic operators.
- Own supplier quality processes, including selection, evaluation, and re-evaluation, SCAR process, and supplier monitoring as a global business process owner.
- Run supplier monitoring boards with cross-functional stakeholders, presenting the status of supplier quality health with metrics on audits, SCARs, supplier nonconformances, and ASL.
- Analyze and review supplier quality processes to ensure compliance with applicable regulations and standards.
- Lead internal CAPAs related to supplier quality and lead high-visibility SCARs and key supplier audits.
- Guide procurement on ASL maintenance and supplier qualifications and inactivations.
- Support internal and external audits, representing supplier quality in audit front rooms.
- Be a technical custodian of supplier data monitoring and analysis.
- Review and approve product SCARs, supplier change requests, and quality agreements.
- Provide guidance to international Agilent sites on local/regional supplier quality execution and maintenance.
- Provide guidance to R&D project teams on supplier selection and onboarding.
- Guide purchasing departments on quality elements of supplier agreement negotiation with suppliers.
Qualifications:
- Bachelor's degree in engineering, pharma, biomedical, health sciences, or equivalent; master's degree preferred.
- Minimum 5 years of experience in supplier quality and/or product quality or related field.
- Excellent knowledge of relevant regulations and certifications.
- Certified ISO 13485:2016 lead auditor credentials or completion of a third-party certification training for lead auditor.
- Strong organizational, written, and verbal communication skills.
- Ability to prioritize tasks effectively in a deadline-driven environment.
- Excellent leadership and project management skills.
- Significant computer experience using Windows, Word, Excel, Agile, and SAP.
- Ability to read and interpret detailed product specifications and communicate technical information.
We Offer:
- Competitive compensation package (estimated salary: €90,000 - €120,000 per year) and benefits.
- Career development opportunities in an international company.
- Work-life balance encouraged.
- Permanent contract in a fast-growing global company.
This is a full-time position with 25% travel required. The schedule is day shift, and there is no end date. The job function is quality/regulatory, and the location is Denmark-Glostrup. We are an equal opportunity employer.
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