Principal Supplier Quality Engineer, Selution

Cordis • Irvine, CA

109d • $111,650 - $165,000

About The Position

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.

Requirements

• 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.

Nice To Haves

• 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.

Responsibilities

• 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.
• 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.
• 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.
• 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.
• 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.

Benefits

• 401k
• health insurance
• dental insurance
• vision insurance
• life insurance
• paid holidays
• paid volunteer time
• tuition reimbursement
• professional development

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Industry: Miscellaneous Manufacturing
• Education Level: Bachelor's degree