IVD Supplier Quality Engineer - Change, Audits & Compliance

Werfen; Lliçà d'Amunt; Vor Ort; EUR 42.000 - 62.000; Vollzeit

Zusammenfassung

Werfen is seeking a Supplier Quality Engineer to join the Biokit team in Barcelona. You will ensure supplier compliance with IVD quality standards, lead audits, and manage change, risk, and CAPA processes to guarantee the highest quality in our diagnostic products.

The role requires a minimum of 3 years in supplier quality, fluency in Spanish or Catalan with strong English, and up to 15% travel. Proficiency in Office and SAP experience are valued assets.

Qualifikationen

• Bachelor’s Degree in Chemistry, Biotechnology, or related Life Sciences (relevant skills and work experience may be considered in lieu of degree).
• Minimum of 3 years in a supplier quality role.
• Fluent in Spanish or Catalan with advanced English.
• Proficient with Microsoft Office; SAP knowledge valued.

Aufgaben

• Evaluate the impact of proposed internal changes and supplier change notifications.
• Establish change validation strategies and review validation documentation.
• Conduct risk assessments to evaluate the impact of changes on the final product.
• Act as Internal Auditor and Supplier Auditor and participate in External Audits.
• Ensure Direct and Indirect/Service suppliers comply with applicable quality standards.
• Manage Non-Conformities, CAPAs, Supplier Complaints, and SCARs.

Kenntnisse

Quality Assurance

Audits

Change Management

Risk Assessment

Supplier Management

Communication

Ausbildung

Bachelor’s Degree in Chemistry or Life Sciences

Tools

Microsoft Office

SAP (basic)

Jobbeschreibung

Werfen is seeking a Supplier Quality Engineer to join the Biokit team in Barcelona. You will ensure supplier compliance with IVD quality standards, lead audits, and manage change, risk, and CAPA processes to guarantee the highest quality in our diagnostic products.

The role requires a minimum of 3 years in supplier quality, fluency in Spanish or Catalan with strong English, and up to 15% travel. Proficiency in Office and SAP experience are valued assets.