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SCIEX · 3 hours ago

Manager, Quality Engineering Operations

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 Manager, Quality Engineering Operations will lead a team of QA Engineers and Technicians to ensure product and process quality across manufacturing operations, focusing on technical troubleshooting, process validation, and continuous improvement.

BiotechnologyManufacturingMedical DeviceProduct Design

H1B Sponsor Likely

Hiring Manager

Lucille Crawford-Sarkodie, MBA-HRM

Responsibilities

Implement Daily Management practices to monitor KPIs and drive rapid issue resolution

Lead process validation, test method validation, and equipment qualification (IQ/OQ/PQ)

Oversee calibration and maintenance programs for equipment reliability

Drive root cause analysis and corrective actions for NCRs, CAPAs, and complaints

Collaborate with Operations and Engineering to improve process capability and reduce variability

Lead continuous improvement initiatives to enhance product quality and operational efficiency

Lead and develop a team of technicians and engineers, including the ability to lead through influence across cross-functional teams

Qualification

Quality AssuranceQuality EngineeringProcess ValidationISO 9001 ComplianceData AnalysisRoot Cause AnalysisCross-Functional CollaborationTechnical TroubleshootingContinuous ImprovementLeadership

Required

Bachelor's degree in Engineering or related technical discipline; advanced degree preferred

Minimum 5 years experience in Quality Assurance or Quality Engineering within a regulated manufacturing environment, including leadership experience

Strong technical knowledge of manufacturing processes, equipment, and validation methodologies

Proven ability to lead hands-on troubleshooting and problem-solving in production environments

Familiarity with ISO 9001 and QSR requirements; experience with audits and compliance

Proficiency in data analysis, SPC, and risk-based decision-making

Ability to work cross-functionally with Operations, Engineering, and Supply Chain teams

Preferred

Leading cross-functional engineering projects focused on process improvement and equipment performance

Managing or supporting site relocation or major facility transitions, ensuring continuity of quality and operations

Chemical or reagent design and manufacturing processes, bringing practical knowledge to QA oversight

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)