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SCIEX · 11 hours ago

Senior Quality Engineer

Carlsbad, CA

Full-time

Onsite

Senior Level

$102K/yr - $178K/yr

5+ years exp

SCIEX has been developing groundbreaking technologies and solutions in mass spectrometry and capillary electrophoresis for over 50 years. The Senior Quality Engineer will support process and product lifecycle management to protect customer satisfaction and business value, while leading quality engineering activities and driving continuous improvement initiatives.

BiotechnologyManufacturingMedical DeviceProduct Design

H1B Sponsor Likely

Hiring Manager

Lucille Crawford-Sarkodie, MBA-HRM

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

Qualification

Quality EngineeringRisk AnalysisDesign of ExperimentsMass SpectrometryCapillary ElectrophoresisISO 13485ISO 9001FDA 21 CFR Part 820Critical ThinkingCollaboration

Required

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

Preferred

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

Benefits

Paid time off

Medical/dental/vision insurance

401(k)

Company

SCIEX

Glassdoor3.3

SCIEX is a biotechnology company that sells mass spectrometers, capillary electrophoresis, and ion sources products.

Founded in 1970

Framingham, Massachusetts, USA

1001-5000 employees

http://www.sciex.com

H1B Sponsorship

SCIEX has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)

Distribution of Different Job Fields Receiving Sponsorship

Represents job field similar to this job

Trends of Total Sponsorships

2025 (1)