Supplier Quality Engineer

Summary

vVARDIS is a Swiss-based oral health company developing innovative biomimetic peptide solutions for preventive dentistry. The Supplier Quality Engineer will own supplier and contract manufacturer quality, including qualification, audits, performance monitoring, nonconformance management, change and risk management, and quality documentation.

Responsibilities

• Lead qualification of new suppliers, contract manufacturers, and critical service providers: questionnaires, document reviews, capability assessments, and on-site audits
• Evaluate suppliers against ISO 13485, EU MDR, FDA 21 CFR 820, OTC monograph, and cosmetics requirements
• Own and maintain the Approved Supplier List (ASL) in the QMS, working with Supply Chain on risk-based selection decisions
• Plan, prepare, and run supplier audits (on-site and remote) against a risk-based annual schedule
• Document findings, issue reports, and chase corrective actions until they're actually closed
• Define and track supplier KPIs: delivery quality, nonconformance rates, CAPA effectiveness, and drive underperformers toward improvement or re-qualification
• Support incoming inspection to ensure materials and components meet specification and release criteria
• Manage supplier-related nonconformances, deviations, and complaints, including CAPA initiation and follow-through
• Assess the quality and regulatory impact of supplier issues and collaborate with QA Operations on disposition decisions
• Review supplier-initiated changes (materials, processes, site transfers) for quality and regulatory impact
• Flag regulatory notification obligations to Regulatory Affairs where they apply
• Develop and maintain Quality Agreements with critical suppliers and contract manufacturers
• Keep supplier documentation current and controlled in the QMS; support supplier-related sections of Technical Files and Design History Files
• Be the go-to quality contact for suppliers on day-to-day matters
• Partner across Supply Chain, R&D, and Regulatory Affairs throughout the product lifecycle
• Build and improve the supplier quality framework itself: templates, tools, processes. If something's missing, build it

Skills

• 3–5 years of dedicated, hands-on Supplier Quality experience in the medical device industry. This is a specialist background, not a generalist QA role. if your experience is primarily internal QA/QMS work with limited direct supplier qualification and auditing exposure, this one isn't the right fit, and that's okay
• Bachelor's or Master's degree in Engineering, Life Sciences, Chemistry, Biomedical Engineering, or a related technical field
• Working knowledge of ISO 13485, EU MDR, and FDA 21 CFR 820 as they apply to supplier management and purchasing controls
• Real, on-the-ground experience conducting supplier audits (on-site and remote) not just familiarity from a distance
• A track record with supplier qualification, CAPA management, and nonconformance handling
• Comfort with risk-based supplier management approaches and quality agreements
• Proficiency with electronic QMS platforms and Microsoft Office
• Willingness and ability to travel for on-site audits

Qualifications

Must Haves

• 3–5 years of dedicated, hands-on Supplier Quality experience in the medical device industry. This is a specialist background, not a generalist QA role. if your experience is primarily internal QA/QMS work with limited direct supplier qualification and auditing exposure, this one isn't the right fit, and that's okay
• Bachelor's or Master's degree in Engineering, Life Sciences, Chemistry, Biomedical Engineering, or a related technical field
• Working knowledge of ISO 13485, EU MDR, and FDA 21 CFR 820 as they apply to supplier management and purchasing controls
• Real, on-the-ground experience conducting supplier audits (on-site and remote) not just familiarity from a distance
• A track record with supplier qualification, CAPA management, and nonconformance handling
• Comfort with risk-based supplier management approaches and quality agreements
• Proficiency with electronic QMS platforms and Microsoft Office
• Willingness and ability to travel for on-site audits