Quality Assurance Specialist
2 months ago
Agilent Technologies is a leading life science, diagnostic, and applied markets company. We provide innovative solutions for customers worldwide, helping them gain answers and insights to improve the world around us. We are seeking a skilled Supplier Quality Engineer to join our team in Denmark-Glostrup.
The ideal candidate will have expertise in Supplier Quality and process improvement, with a strong understanding of regulations such as 21 CFR part 820, ISO 13485:2016, and IVDR. Key responsibilities include ensuring compliance with regulations, leading Supplier Quality Compliance Projects, developing Partner Quality Agreements, and conducting key Supplier Audits. The successful candidate will be a true team player, able to work with highly technical teams and communicate effectively at an executive level.
Responsibilities
- Lead Projects as a Project Manager to improve Supplier Quality Processes.
- Compile key Quality Agreements for Business Expansion.
- Own Supplier Quality processes, including Supplier Selection, Evaluation, and Re-Evaluation.
- Run Supplier Monitoring Boards with cross-functional stakeholders.
- Work with Regulatory Affairs/Quality Systems team to analyze and review Supplier Quality processes.
- Lead internal CAPAs related to Supplier Quality.
- Lead high-visibility SCARs and Key Supplier Audits.
- Guide Procurement on ASL maintenance and Supplier Qualifications.
- Support Internal and External Audits representing Supplier Quality.
- Be a technical custodian of Supplier Data Monitoring and Analysis.
Requirements
- BS degree in Engineering, Pharma, Biomedical, Health Sciences, or equivalent.
- Minimum 5 years related experience in Supplier Quality and/or Product Quality.
- Excellent knowledge of 21 CFR part 820, ISO 13485:2016, IVDR regulations.
- Certified ISO13485:2016 Lead auditor credentials preferred.
- Ability to work with highly technical teams and communicate effectively.
- Strong organizational, written, and verbal communication skills.
- Excellent Leadership and Project Management skills.
- Significant computer experience using Windows, Word, Excel, Agile, and SAP.
This is a full-time role with a competitive compensation and benefits package, career development opportunities, and a permanent contract in a fast-growing global company. Agilent Technologies is an equal opportunity employer.
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