Senior Quality Engineer (On site)
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. 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
- Requires Engineering Bachelors Degree plus 5+ years of relevant experience.
- Expertise in the FDA Medical Device Quality System Regulation, MDR, MDSAP and ISO 13485
Responsibilities
- Maintain and improve the effectiveness of the Quality Management System in compliance with applicable regulatory and quality standards.
- Support quality system processes including: Corrective and Preventive Actions (CAPA), Nonconforming Material Reports (NCMR), Complaint Handling, Internal Audits, Document Control, Training Compliance, Change Control.
- Review, investigate, approve, and monitor quality records to ensure timely closure and regulatory compliance.
- Identify quality system gaps and implement corrective actions to improve compliance and operational effectiveness.
- Serve as a key participant during external audits and inspections conducted by regulatory agencies, notified bodies, customers, and certification organizations.
- Partner with Manufacturing and Engineering teams to address product and process quality issues.
- Drive root cause investigations and risk-based decision making for quality events.
- Escalate issues through the Nonconformance and CAPA processes when appropriate.
- Support process validation, product transfers, and continuous improvement initiatives.
- Participate in product risk management activities, including Distributed Product Risk Assessments (DPRA) and risk mitigation efforts.
- Monitor and analyze quality metrics to identify trends, risks, and opportunities for improvement.
- Prepare and present quality performance data during Management Review meetings.
- Lead or support medium-complexity projects focused on process improvement, compliance enhancement, and operational excellence.
- Drive initiatives that improve product quality, process efficiency, and customer satisfaction.
- May provide functional leadership or supervision of technician-level personnel as assigned.
- Communicate significant quality, compliance, and business-related issues to management in a timely manner.
- Ensure compliance with all applicable federal, state, local, and international regulations, company policies, and quality procedures.
- Support Environmental Health & Safety (EHS) requirements and promote safe work practices.
- Perform additional duties and responsibilities as assigned.
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What This Job Offers
Job Type
Full-time
Career Level
Senior
