Senior Engineer Quality - Finished Device Manufacturing (Onsite)

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.

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.

Responsibilities:

We are seeking a Senior Quality Engineer (QE) to provide end-to-end quality leadership supporting the establishment of manufacturing infrastructure and finished device manufacturing programs, with experience as a supplier of finished medical devices and/or a Private Label manufacturer. This role supports product development through validation, PPQ, and sustained manufacturing operations. The ideal candidate is hands-on, decisive, and comfortable operating across Engineering, Manufacturing, Supplier Quality, and Regulatory environments in a fast-paced medical device setting.

Key Responsibilities

Validation & Process Readiness

• Lead Quality activities for Receiving Inspection (RI) stand-up, including inspection methods, sampling plans, documentation, and workflows for new components.
• Support IQ, OQ, and PPQ activities, including protocol development, execution support, deviation management, and documentation review and approval.
• Ensure validation activities are audit-ready and compliant with internal procedures and regulatory expectations.

Manufacturing & Floor Support

• Provide day-to-day QA support on the manufacturing floor, particularly during first builds and PPQ execution.
• Develop and implement QCI work instructions for inspection and documentation processes.
• Rapidly assess and resolve quality issues to prevent production delays.

Release & Manufacturing Readiness

• Establish and support QCI release and final release workflows for finished devices.
• Ensure release processes are robust, compliant, and scalable for commercial manufacturing.

Supplier & Incoming Quality Support

• Monitor supplier performance and manage supplier-related quality issues.
• Lead or support SCARs, audits, investigations, and corrective actions as required.
• Ensure incoming material controls align with manufacturing and PPQ requirements.

Operational Quality & Change Management

• Lead and manage Nonconformances (NCs), investigations, and dispositions.
• Drive Change Management (CM) activities, including risk assessments, approvals, and implementation coordination.
• Lead and support CAPA activities to address systemic quality issues.
• Support audits, customer issues, and continuous improvement initiatives.

Qualifications:

Required Qualifications

Requires Engineering Bachelors Degree plus 5+ years of relevant experience.

Hands-on experience with IQ, OQ, PPQ, and process validation.

Strong working knowledge of FDA QSR (21 CFR 820) and ISO 13485.

Proven experience supporting manufacturing floor operations.

Demonstrated ability to manage NCs, SCARs, CAPA, and change control processes.

Strong cross-functional communication and execution skills.

Preferred Qualifications:

• Experience standing up new inspection or manufacturing processes.
• Experience as a supplier of finished medical devices and/or Private Label manufacturer.
• Supplier quality and/or B2B manufacturing experience.
• Ability to operate independently in high-visibility, fast-paced programs.

Why This Role Matters

This role is critical to enabling compliant, scalable finished device manufacturing by first building the right infrastructure and then sustaining high-performing manufacturing programs. It offers high visibility, direct ownership, and meaningful impact on manufacturing quality and operational readiness.

Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities

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.