Senior Quality Engineer

Leica Microsystems • Carlsbad, CA

2d

About The Position

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. Do you want to make history in a company that advances human wellness through the power of precise science? To be part of dynamic collaborations that drive results that enable SCIEX to deliver growth and innovative, reliable solutions 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 team's 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.

Requirements

• Bachelor's degree with 5+ years of relevant experience, or Master's 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 processes—evaluating 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.

Nice To Haves

• 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.

Responsibilities

• 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.

Benefits

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

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 1,001-5,000 employees