Principal Supplier Quality Engineer, Selution

Job description

**Overview**

When you join the team at Cordis, you become part of an inspiring mission to save lives, impacting millions of people and broadening access to life-saving cardiovascular and endovascular technology.

As a global leader for over 60 years, we are dedicated to being the heart of innovation to transform cardiovascular care.

Our flagship product, SELUTION, combines pharmaceuticals with a traditional balloon catheter, revolutionizing treatments for coronary and peripheral artery diseases.

With four Investigational Device Exemptions (IDEs) approved and actively enrolling patients (Coronary ISR, Coronary De Novo, Peripheral SFA, and Peripheral BTK), Cordis is leading the way in delivering transformative medical solutions.

At Cordis, we’re teammates, not just employees.

We embrace an empowered and one-team culture where teammates are inspired to unleash their full potential.

With diverse teams on a global scale, we believe the richness of our experiences and backgrounds enhances the careers of our teammates, the service to our customers, and ultimately, the lives of our patients.

If you love a challenge and are ready to have a direct, transformative and positive impact on the lives of millions, then Cordis is just the place for you.

**We are the people behind the people who keep saving lives.**

The **Principal Supplier Quality Engineer (SQE)** will be responsible for ensuring the quality and compliance of suppliers and components used in the company’s products.

This role involves qualifying new suppliers, assessing component quality, managing supplier performance, resolving non-conformances, driving corrective actions, and conducting supplier audits.

The Principal SQE will also collaborate closely with R&D and commercial teams to mitigate risks and ensure smooth project execution.

**Responsibilities**

+ **Supplier Qualification & Component Approval**

+ Lead the qualification process for new suppliers and ensure compliance with regulatory and company standards.
+ Perform supplier assessments, audits, and technical reviews to verify capabilities.
+ Qualify components and ensure adherence to product specifications and performance criteria.

+ **Supplier Performance & Compliance Management**

+ Conduct periodic supplier performance reviews, tracking KPIs such as quality, delivery, and compliance.
+ Drive continuous improvement initiatives with suppliers to enhance quality and reliability.
+ Address and resolve supplier-related quality issues, ensuring timely corrective and preventive actions.

+ **Non-Conformance & Corrective Action Management**

+ Investigate supplier non-conformances and collaborate on root cause analysis.
+ Manage Supplier Corrective Action Requests (SCARs) and ensure effective resolution.
+ Implement risk mitigation strategies to prevent recurring quality issues.

+ **Supplier Audits & Compliance**

+ Plan and execute supplier audits to ensure adherence to industry standards and company requirements.
+ Ensure supplier processes align with ISO, FDA, and other regulatory requirements.
+ Provide guidance to suppliers on quality expectations and compliance improvements.

+ **Cross-Functional Collaboration**

+ Work closely with R&D, Operations, and Commercial teams to support supplier-related needs.
+ Provide technical guidance and quality input during product development and commercialization.
+ Act as a liaison between suppliers and internal teams to resolve quality-related challenges.

**Qualifications**

+ Bachelor’s degree in Engineering, Quality, or a related field.

Master’s degree preferred.
+ 8-10 years of experience in supplier quality engineering, supplier management, or a related role.
+ Strong knowledge of supplier qualification, component validation, and quality systems.
+ Experience conducting supplier audits and working with SCAR processes.
+ Familiarity with regulatory and compliance requirements (ISO 13485, FDA, ISO 9001, etc.).
+ Excellent problem-solving, analytical, and negotiation skills.
+ Ability to travel as needed for supplier audits and collaboration.

**Preferred Qualifications:**

+ Experience in the medical device, automotive, or high-tech manufacturing industries.
+ Certifications such as Six Sigma, ASQ Certified Supplier Quality Professional (CSQP), or Lead Auditor.
+ Proficiency in statistical analysis, FMEA, and risk management methodologies.

Pay / Compensation
The expected pre-tax pay rate for this position is $111,650 - $165,000 per year
Actual pay may fluctuate outside of the listed range depending on skills, education, experience, job-related knowledge and location.

US work authorization is a precondition of employment.

The company will not consider candidates who require sponsorship for a work-authorized visa.

Cordis is proud to be an equal opportunity employer and is committed to providing equal opportunity for all teammates and applicants.

At Cordis, our teammates all bring different strengths, experiences, and backgrounds, who share a passion for improving people's lives.

Diversity not only includes race and gender identity, but also age, disability status, veteran status, sexual orientation, religion, and many other parts of one’s identity.

All our teammate’s points of view are key to our success, and we believe inclusion is everyone's responsibility.

Together, we strive to create and maintain working and learning environments that are inclusive, equitable and welcoming.

**JOIN OUR TALENT COMMUNITY**
Joining our Talent Community is a great way to receive company news and updates, as well notifications on career opportunities and events that interest you! Please tell us more about yourself so we can align you with future opportunities that match your background, skills and interests.

**Job Locations** _US-CA-Irvine_
**ID** _2025-3482_

**Category** _Quality/Regulatory_

**Position Type** _Regular Full-Time_
CORDIS is proud to be an equal opportunity employer, values diversity in all its forms is and committed to fostering an inclusive work environment.

We are committed to advancing our culture of belonging, where all teammates feel seen, heard, and appreciated and encouraged to be their authentic selves.

Our team is invested in attracting, retaining and growing top talent.

Our Teammates are the core of our innovation and success.

Cordis is an inclusive, engaging place to work and grow a career.

CORDIS is committed to offering reasonable accommodations, upon request, to job applicants with disabilities.

If you need assistance or an accommodation due to a disability, please contact GlobalHR@Cordis.com

Required Skill Profession

Other General