Senior Quality Engineer

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 youll find a rewarding role that amplifies your impact on the world and helps you realize lifes 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.

Do you want to make history in a company that advances human wellness through the power of precise science To be part of dynamic collaborationsthat drive results that enable SCIEX to deliver growth and innovative reliablesolutions for customers worldwide

The Senior Quality Engineer is a technical Quality subject matter expert that supports process and product lifecycle through management of risk to protect customer satisfaction and business value. This role will empower Carlsbad plant in becoming the functionally competent center of excellence for consumables for SCIEX and instrument company.

This position is part of the Quality Assurance and Regulatory Affairs department and will be in Carlsbad. Our teams vision is to deliver world-class quality through proactive risk management technical excellence and operational efficiency.

In this role you will have the opportunity to:

• Lead quality engineering activities for new product development (NPD) and design transfer ensuring readiness for commercial launch while operating with independence and accountability.
• Develop and execute Quality Plans in collaboration with cross-functional teams applying statistical methods risk analysis and design of experiments to drive robust product and process outcomes.
• Create review and approve design validation and verification protocols ensuring traceability to technical and regulatory requirements and applying critical thinking to resolve complex challenges.
• Provide technical oversight for product changes and process validations (IQ/OQ/PQ) including risk assessments compliance verification and coaching teams on rigorous decision-making.
• Drive continuous improvement initiatives to enhance product quality and manufacturing processes fostering strong team engagement and collaboration.

The essential requirements of the job include:

• Bachelors degree with 5 years of relevant experience or Masters degree with 3 years in Quality Engineering or a related field.
• Familiarity with the operation and functionality of Mass Spectrometry and Capillary Electrophoresis instruments.
• Proven ability to apply statistics design of experiments (DOE) and risk analysis in developing Quality Plans and reviewing validation/verification protocols for compliance and technical soundness.
• Skilled in overseeing product change processesevaluating rationale conducting cross-functional risk assessments and ensuring compliance for both permanent and temporary changes.
• Demonstrated ability to work independently exercise sound judgment and apply critical thinking while maintaining strong collaboration with cross-functional teams.

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

• Direct QC Testing: Hands-on experience performing quality control testing on Mass Spectrometry and Capillary Electrophoresis instruments for both production and investigational/manufacturing transfer protocols.
• Working knowledge of ISO 13485 ISO 9001 and FDA 21 CFR Part 820 as applied to manufacturing.
• Familiarity with quality systems and continuous improvement methodologies with a strong focus on team engagement and driving collaborative solutions.

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

The annual salary range OR the hourly range for this role isUSD annual. This is the range that we in good faith believe is the range of possible compensation for this role at the time of this posting.

This job is also eligible for bonus/incentive pay.

We offer comprehensive package of benefits including paid time off medical/dental/vision insurance and 401(k) to eligible employees.

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 Companys sole discretion unless and until paid and may be modified at the Companys sole discretion consistent with the law.

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Join our winning team today. Together well accelerate the real-life impact of tomorrows 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.

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