Experience Inc. Jobs

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 (https://www.danaher.com/how-we-work/danaher-business-system) which makes everything possible.

The Senior Manager, Design Quality Engineering brings a high degree of technical expertise and process knowledge to new product innovation, design, and sustaining engineering projects and leads a team of quality engineers responsible for providing advanced process and quality engineering support to R&D and manufacturing. The Senior Manager’s goal is to ensure the design and development of the highest quality products for our customers collaborating with executive leadership on quality strategy while driving continuous process improvement.

In this role, the incumbent will drive significant impact within the organization, lead exciting projects, and experience continual professional growth. This position is part of the Quality Assurance and Regulatory Affairs team and will be located in Concord, Ontario, Canada.

In this role, you will have the opportunity to: 

• Lead and manage a team of Quality Engineers including resource allocation, budgeting, and project management and support the performance and development objectives of the Quality Engineers and engage in mid-year and end of year progress discussions. Provide Quality Engineering support for NPI teams for the development of hardware, software, and consumable products for both IVD/MD and RUO products.

• Provide comprehensive Quality Engineering support by collaborating with the IQC team to identify and manage defective material through the NCMR (Nonconforming Material Report) process.

• Oversee and execute first article inspection activities as required by the NPI team in Concord.

• Support the engineering team by performing detailed, technically critical reviews and approvals of Engineering Change Requests and Engineering Change Orders.

• Work closely with cross-functional teams to ensure strict adherence to procedures as mandated by the SCIEX Quality Management System.

• Support the audit program by providing subject matter expertise.

• Manage timely risk evaluations of issues for commercial product, globally, and coordinate with Regulatory Affairs and Customer Quality as required for post market surveillance activities.

The essential requirements of the job include:  

• Bachelor’s degree in engineering (advanced degree preferred)

• 7+ years of experience in quality engineering and a minimum of 5 years’ experience leading quality engineering professionals.

• Extensive experience leading and supporting design processes for new product introduction, preferably with software driven instrumentation.

• Experience with incoming inspection and nonconforming materials process.

• Proven experience providing quality support for New Product Introductions.

• Demonstrated experience with Engineering Change Requests and Change Orders.

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

• Self-motivated and capable of managing a team in a highly technical, fast-paced environment, with clear and effective communication skills.

• Demonstrated experience working collaboratively with various functions, including design engineering, operations, and manufacturing.

• Strong analytical, technical writing, verbal communication, and interpersonal skills.

• Thorough understanding of ISO 13485, ISO 9001, FDA QSR and EU IVD regulations.

Travel, Motor Vehicle Record & Physical/Environment Requirements:

• Must be able to accommodate up to 10% international travel

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.

#LI-LCS

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.