Supplier Quality Engineer

vVARDIS; United States; On-site; USD 110,000 - 160,000; Full time

Job summary

vVARDIS is seeking a Supplier Quality Engineer to own the quality of externally sourced materials, components, and services. You will qualify new suppliers, audit them, and track performance to ensure all inputs meet patient safety standards.

You will partner with Quality, Operations, R&D, and Regulatory Affairs, leading risk-based supplier management and driving improvements. Travel for on-site audits will be required; role reports to Senior Manager, Quality Engineering & Operations.

Qualifications

• 3–5 years of hands-on supplier quality experience in medical devices.
• Bachelor's or Master's degree in Engineering, Life Sciences, or related field.
• Experience with ISO 13485, EU MDR, and FDA 21 CFR 820 in supplier mgmt.

Responsibilities

• Lead qualification of new suppliers and contract manufacturers.
• Plan, prepare, and run supplier audits on-site and remote.
• Maintain the Approved Supplier List (ASL) in the QMS.
• Define and track supplier KPIs and CAPA effectiveness.
• Manage supplier-related nonconformances and deviations.
• Develop and maintain Quality Agreements with suppliers.

Skills

Supplier quality

Auditing

ISO 13485

CAPA management

Education

Bachelor's or Master's in Engineering/Life Sciences

Tools

eQMS platforms

Microsoft Office

Job description

vVARDIS is a Swiss-based oral health company founded by Dr. Haley and Dr. Goly Abivardi, dentists, innovators, and award-winning entrepreneurs. vVARDIS is the result of a combined 30 years of dental and entrepreneurial experience, and 20 years of laboratory and clinical research paired with the creative vision of its founders.

At vVARDIS, we are committed to delivering innovative solutions that enhance oral health and well-being, inspired by the vision of our founders to foster preventive rather than reparative dentistry. At the heart of our Company lies its patented, revolutionary biomimetic peptide technology. Scientifically proven in over 200 publications, this unique technology can treat early caries through enamel regeneration, offering a non‑invasive, pain‑free solution for patients of all ages. Our portfolio includes oral health products for dental professionals, patients, and consumers, all based on our proprietary technology.

We are located in Zug, Switzerland, with operations in Europe and the US. Join us on this exciting journey.

Purpose:

As our Supplier Quality Engineer, you'll own the quality of everything that comes into vVARDIS from the outside world: our suppliers and contract manufacturers. From qualifying new suppliers to auditing them, tracking their performance, and resolving issues when they arise, you're the person making sure every material, component, and service meets the bar our patients deserve.

This is a hands‑on, high‑visibility role. You'll partner closely with Quality, Operations, R&D, and Regulatory Affairs, reporting to the Senior Manager, Quality Engineering & Operations, but you'll be trusted to run your area independently from day one.

We need someone who can hit the ground running. This isn't a role to learn supplier quality on the job, it's a role for someone who already knows it cold and is ready to make an immediate impact.

What You Will Own:

• 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.

Incoming Quality & Nonconformance Management

• 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.

Agreements & Documentation

• 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.

Cross‑Functional Impact

• 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.

What You Bring:

• 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.

Who Thrives Here:

You're someone who's fine walking alone when you need to, figuring it out, making the call, and moving before anyone tells you to. You grab the chances that come your way with joy and excitement. You're excited about growth, your own and the company's, but you also just do what lands on your table, even when it's not glamorous.

You're analytical and detail‑oriented, but you don't hide behind process. You drive suppliers and internal partners to actual resolution. You know a supply chain isn't a paperwork exercise; it's patient safety. And you want to help build something special, at a company that's as innovative as its product.

vVARDIS is an equal opportunities employer and welcomes applications from all suitably qualified persons.