Cordis · 14 hours ago
Senior Engineer Quality - Finished Device Manufacturing (Onsite)
Miami Lakes, FL
Full-time
Onsite
Senior Level
5+ years expCordis is a global leader in cardiovascular and endovascular technology dedicated to saving lives. They are seeking a Senior Quality Engineer to provide leadership in quality assurance for manufacturing infrastructure and finished device programs, ensuring compliance and operational readiness.
Health CareHealth DiagnosticsMedical
Responsibilities
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
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
Establish and support QCI release and final release workflows for finished devices
Ensure release processes are robust, compliant, and scalable for commercial manufacturing
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
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
Qualification
Required
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
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
Company
Cordis
Cordis Corporation, a Johnson & Johnson company, has pioneered less invasive treatments for vascular disease.
1001-5000 employees
H1B Sponsorship
Cordis has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (5)
2024 (3)
2023 (3)
2022 (4)
Funding
Current Stage
Late StageTotal Funding
unknown2021-03-12Acquired
Leadership Team
Scott Drake
Chief Executive Officer
Recent News
2025-11-11
TeamBest Global Companies
2025-11-07
News-Medical.Net
2025-11-01
Company data provided by crunchbase