Design Quality Engineering Manager (Onsite)

Cordis; Florida; In loco; USD 120.000 - 180.000; Tempo pieno

Descrizione del lavoro

Cordis is seeking a senior Design Quality leader in Florida to oversee QA activities for new product development and new business development, ensuring regulatory compliance and robust DHF. You will guide a team of Design Quality Engineers, set QA strategy, and partner with cross-functional stakeholders to expedite safe and compliant product launches.

The role emphasizes leadership in design control, risk management, supplier quality, and continuous improvement across R&D and manufacturing.

Competenze

• Requires a total minimum of 8+ years of relevant experience.
• Thorough knowledge of the device R&D process and QA practices.

Mansioni

• Oversee Design Quality Engineering group day-to-day and priorities.
• Develop and update operating procedures; set goals.
• Hire, train and develop staff to meet regulatory requirements.
• Estimate budgets and manage costs for the department.
• Lead QA activities for NPD/NBD projects and supplier QA.
• Support external audits related to Design Control and Risk.

Conoscenze

QA leadership

Regulatory compliance

Design QE

Cross-functional

Budgeting

Staff development

Quality systems

Design reviews

Communication

Formazione

Bachelor's degree or equivalent

Advanced/graduate degree preferred

Strumenti

Design Control

CAPA

Quality Systems

Descrizione del lavoro

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.

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

This position plans, executes and manages design quality assurance activities related to new product development (NPD) and new business development (NBD), ensuring compliance with regulatory and company requirements.
Directly responsible for effective oversight of Design Quality Engineers, departmental systems, staff development, and personnel performance maintenance. Provide QA leadership and strategic approaches, and partner with cross functional stakeholders. Promote efficient, effective and rapid development and commercialization.

Essential Duties And Responsibilities

• Oversee the day to day and priorities of the Design Quality Engineering group.
• Cooperate with other management personnel in formulating, establishing and updating operating procedures, and goals.
• Hires, trains and develops immediate staff to meet and exceed the current regulatory requirements, and proper procedures related to Design QE activities. Ensures the adequacy of QA procedures and performance of QA staff.
• Estimates budget for the Design QE department and maintain operating costs within constraints of those budgets.
• Carrys out supervisory responsibilities in accordance with the organization's policies and applicable laws.
• Responsible for communicating business related issues or opportunities to next management level.
• Responsible for ensuring that subordinates follow all company guidelines related to Health, Safety and Environmental practices and that all resources needed to do so are available and in good condition.
• Ensures the organization is alerted to issues in time to resolve potential impacts to the business.
• Ensures effective technical design reviews and effective implementation and utilization of quality tools within research and development and new product development.
• Guides high-level engineers in development and deployment of innovative quality engineering tools, techniques and systems that will drive product development to successfully achieve key business results.
• Leads Design Quality Engineers in support of NPD/NBD Projects. Responsibilities of Design QE include the following: Review/Approval of Design Characterization, Design Planning, Design Input, Design Output, Design Verification and Validation, Operational Qualification, Performance Qualification, Risk Management, Labeling Development, Competitive Testing, Design Transfer and Launch Planning, Design History File (DHF) verification, as well as new product supplier quality engineering responsibilities, including Supplier Quality Agreements and Supplied Item/process qualifications. Responsibilities of NBD include Supplier Quality Agreements, Applicable Design Control Deliverables determination, Supply Chain and Launch Planning, Finished Device Qualification and Direct Ship Strategy, as applicable.
• Leads Design Quality Engineers in data analysis support for R&D projects where applicable.
• Support Complaints and Escalation or applicable CAPAs for recent project launches (pre-phase 6 closure)
• Support Post Launch design and/or significant process change projects, as applicable.
• Support External Audits in areas of Design Control, Product Risk Management, and Recent Project Launches, as applicable.
• Responsible for acquiring and maintaining current knowledge of applicable Design Quality Engineering requirements and trends.
• Talent Management (recruiting, hiring, termination, performance management and leadership development) for their organization

Qualifications

Required Qualifications

• University degree or the equivalent combination of education and experience required. Advanced/graduate degree preferred for some disciplines. Requires a total minimum of 8+ years of relevant experience
• Requires a thorough knowledge of the device research and development process, related national and international regulations and guidance documents, engineering and scientific terminology, and QA practices. Requires excellent communication skills (written and oral) and a fine sense of attention to detail where needed

Preferred Qualifications

• Read, analyze and interpret engineering and quality documents
• Effectively motivate staff and department
• Respond effectively to sensitive inquiries
• Prepare/present formal, effective presentations using original or innovative techniques/styles to top management
• Define problem scope, collect data, establish facts, and draw valid conclusions
• Effectively utilize PCs and associated software to augment department efficiency
• Effectively deal with representative of various government agencies
• Effectively deal with a variety of conflicting issues, efficiently prioritize and diplomatically solve those issues
• ASQ Certification as a Certified Quality Engineer or Certified Quality Manager is an asset

ADDITIONAL POSITION REQUIREMENTS

Travel requirement: approximately 20%

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.