Senior Quality Assurance Specialist
2 days ago
We are seeking a Senior Quality Assurance Specialist to join our team in Denmark or Waldbronn.
Job SummaryThis full-time role is responsible for ensuring compliance with various Regulations and Standards, leading Supplier Quality Compliance Projects, developing Partner Quality Agreements, managing high visibility SCARs, and conducting key Supplier Audits. The ideal candidate will have expertise in Supplier Quality and a passion for process improvement.
Key Responsibilities:- Lead Projects as a Project Manager to improve Supplier Quality Processes to improve efficiency and address compliance gaps.
- Compile key Quality Agreements for Business Expansion with Agilent's Partners (as Reseller, Distributor or as any IVDR Economic Operator).
- Own Supplier Quality processes including Supplier Quality, Supplier Selection, Evaluation and Re-Evaluations, 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.
- Work with Regulatory affairs/Quality Systems team and Periodically analyze and review Supplier Quality processes to stay in compliance with latest applicable Regulations and Standards.
- Lead internal CAPAs related to Supplier Quality.
- Lead high visibility SCARs and Key Supplier Audits (Evaluations and Re-Evaluations) as a Lead Auditor.
- Guide Procurement on ASL maintenance and Supplier Qualifications and Inactivation's.
- Support Internal and External Audits (FDA, MDSAP, IVDR etc.) representing Supplier Quality in Audit Front rooms.
- Be a technical custodian of Supplier Data Monitoring and Analysis. Analyze and prepare data for Supplier Monitoring Boards and monitor tools and dashboards for accuracy.
- 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 department on Quality elements of Supplier Agreement negotiation with Suppliers
To be successful in this role, you will need:
- BS degree in Engineering, Pharma, Biomedical, Health Sciences or equivalent, Masters degree preferred
- Minimum 5 years related experience in Supplier Quality and/or Product Quality or related field.
- Excellent knowledge of 21 CFR part 820, ISO 13485:2016, IVDR, MDSAP regulations (experience in auditing suppliers to these standards)
- Certified ISO13485:2016 Lead auditor credentials preferred or Completion of a 3rd party certification training for Lead Auditor.
- Ability to be a true team player and a partner to the cross-functions teams; be part of the solution and demonstrate ability to use sound judgment in implementing practical Quality System and Compliance solutions.
- Ability to work with highly technical teams and effectively communicate in an engineering-driven team environment
- Strong organizational, written, and verbal communication skills and the proven ability to prioritize tasks effectively in a deadline-driven environment and presentations to executive level management.
- Excellent Leadership and Project Management skills
- Significant computer experience using Windows, Word, Excel, Agile, and SAP
- Ability to read and interpret detailed product specifications (reagents, diagnostic devices) and communicate technical information.
The salary for this role is approximately €70,000 - €90,000 per year, depending on location and experience.
We offer a competitive compensation and benefits package, career development opportunities in an international company, work-life balance, and a permanent contract in a fast-growing global company.
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