Director, Customer Quality (Customer Complaints, Medical Device)

For over 50 years, SCIEX has been developing groundbreaking technologies and solutions in mass spectrometry and capillary electrophoresis. Our products enable our customers to quickly respond to environmental hazards, better understand biomarkers relevant to disease, improve patient care in the clinic, bring relevant drugs to market faster and keep food healthier and safer. At SCIEX, you’ll find a rewarding role that amplifies your impact on the world and helps you realize life’s potential.

SCIEX is one of 10 Life Sciences companies of Danaher. Together, we accelerate the discovery, development and delivery of solutions that safeguard and improve human health.

Learn about the Danaher Business System which makes everything possible.

The Director, Customer Quality, is responsible for leading the global customer quality functions including Customer Defect Tracking & Resolution and Complaints Teams. This position is part of the Quality Assurance & Regulatory Affairs organization and will be located ON-SITE in Ontario, Canada at our Concord office. In that role you will report to the Vice President, Quality Assurance & Regulatory Affairs.

In this role, you will have the opportunity to: 

• Lead the Global Customer Quality functions including Customer Defect Tracking & Resolution and Complaints Teams by utilizing the Danaher Business System (DBS) and Danaher Reliability System processes to drive continuous improvement of the external Quality Core Value Drivers.
• Manage the customer Quality Agreement processes supporting commercial sales including timely notifications of design changes.
• Direct, coordinate and execute field action processes, globally including tracking and verification of effectiveness collaborating with regional teams as needed.
• Leverage DBS and QARA Portfolio Management to drive standardization, simplification, and optimization in QARA and related business processes with the DBS Leader and cross functional teams.
• Lead the Leadership Focus on Reliability program to support maturity of the five pillars to improve the customer experience and provide influential guidance to organizational leaders on process improvement.
• Actively participate in the development and execution of strategic initiatives, kaizen events, and operational leadership meetings to support the Quality Assurance & Regulatory Affairs team and perform other duties as assigned including special projects.
• Collaborate cross-functionally to drive continuous improvement in customer satisfaction through design assurance, supplier quality improvement, manufacturing process controls, and service activities.

The essential requirements of the job include: 

• Bachelor of Science degree in a relevant scientific discipline
• Prefer 10+ years of experience in quality and compliance and prefer 5+ years of experience building and leading teams
• Knowledge of ISO 9001, ISO 13485, and US FDA 21 CFR Part 820 Quality Systems regulations
• Excellent analytical and problem-solving skills with the ability to effectively communicate complex ideas and data to influence executive leadership
• Exceptional time management and organizational skills
• Experience with mass spectrometry, liquid chromatography, and capillary electrophoresis preferred

Travel, Motor Vehicle Record & Physical/Environment Requirements:

• Ability to travel up to 15% to SCIEX and Danaher locations and customer sites

It would be a plus if you also possess previous experience in: 

• Working knowledge of statistical analysis application for data modeling
• Project management or program management preferred

SCIEX, a Danaher company, offers a broad array of comprehensive, competitive benefit programs that add value to our lives. Whether it’s a health care program or paid time off, our programs contribute to life beyond the job. Check out our benefits at danaherbenefitsinfo.com.

This job is also eligible for bonus/incentive pay.

Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company’s sole discretion unless and until paid and may be modified at the Company’s sole discretion, consistent with the law.

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At Danaher we bring together science, technology and operational capabilities to accelerate the real-life impact of tomorrow’s science and technology. We partner with customers across the globe to help them solve their most complex challenges, architecting solutions that bring the power of science to life. Our global teams are pioneering what’s next across Life Sciences, Diagnostics, Biotechnology and beyond. For more information, visit www.danaher.com.

At Danaher, we value diversity and the existence of similarities and differences, both visible and not, found in our workforce, workplace and throughout the markets we serve. Our associates, customers and shareholders contribute unique and different perspectives as a result of these diverse attributes.

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