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.

Responsibilities

The Principal Quality Engineer will join the Selution DCB operations team, they will predominantly be responsible for driving the organization through continuous improvement initiatives (lean, six Sigma, SPC). This will require evolving the existing data bases to generate site wide visual management communications and holding the organization accountable to both recognizing and actioning trends. Additionally, the roles focus on implementing and maintaining process control systems, analyzing performance data, and driving continuous improvement initiatives to enhance product quality and operational efficiency.

Details of the Function

1.1. Key Accountabilities

• Develop and implement statistical process control (SPC) methods for monitoring and improving production quality.
• Supports operations on process validation and qualification activities (IQ/OQ/POQ) in compliance with industry practice.
• Partner with cross functional teams such as manufacturing, R&D, and suppliers to resolve process and quality issues.
• Analyze process and product data to identify trends, variations, and areas for improvement
• Lead Monitoring, process performance metrics, and lead continuous improvement initiatives using common tools like Lean, Six sigma.
• Mentor junior engineers and provide technical leadership on quality and compliance topics.
• Regulatory Compliance: Stay up to date with regulatory requirements, standards, and guidelines relevant to the medical device industry and ensure that manufacturing processes adhere to these regulations.
• Root Cause Analysis: Investigate and resolve quality issues by performing root cause analysis and implementing corrective and preventive actions.
• Documentation: Maintain accurate and complete documentation of quality-related processes, inspections, and testing, ensuring compliance with Good Manufacturing Practices (GMP).
• Audit Support: Support internal and external audits, including FDA inspections, by providing documentation, data, and expertise related to manufacturing quality.

Strategic Impact

• Establish a data driven culture & propose strategy for management decisions
• Quality support to develop next gen process and ramp up to meet market requirements
• Quality lead on support and implementation of revised QS

Key Interactions

• Reports to a - leadership position.
• Potential to interact with all functions including suppliers and customers depending on the topic/project being led or supported.

Qualifications

1.1. Education and Work Experience

• Bachelor’s degree in mechanical engineering, Biomedical Engineering, or a related field.
• Strong knowledge of SPC, FMEA, MSA, and other quality tools
• At least 7 years and up years in medical device production development
• Six Sigma black or green belt, CRE, CQE or CQT [preferred]
• Previous experience with product lifecycle (post market) commercial support [preferred]
• Previous experience working in a clean room environment [preferred]

Competencies & Skills

• Strong engineering and quality background
• Hands-on experience with control charts, process mapping, and DOE (Design of experiments)
• Team Leader, ability to inspire and support a team.
• Proven track record in global regulatory body interactions
• Strong communication skills.
• Global, International Orientation
• Ability to make independent decisions
• Fluent in English

Physical Requirements

• Light office work and telecommute capability.
• Available to travel 10% of the time, as required domestic and international
• Must be able to lift and carry up to 15 lbs.

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