Manager, Quality Engineering Operations
Listed on 2026-03-07
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Engineering
Quality Engineering
SCIEX – Manager, Quality Engineering Operations – Carlsbad, CA
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 disease biomarkers, improve patient care, bring drugs to market faster, and keep food safer and healthier. As part of Danaher, SCIEX accelerates the discovery, development, and delivery of solutions that safeguard and improve human health.
Responsibilities- Lead a team of QA Engineers and Technicians to ensure product and process quality across manufacturing operations.
- Maintain a full QMS compliant with the site‑specific ISO 9001 certificate, including managing audits by regulatory authorities and customers.
- Focus on technical troubleshooting, process validation, equipment qualification, and supplier quality engagement.
- Lead continuous improvement projects, collaborate with cross‑functional teams, and make a direct impact on operational performance.
- 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 leading through influence across cross‑functional teams.
- Bachelors degree in Engineering or related technical discipline; advanced degree preferred.
- Minimum 5 years of 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.
- 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.
The annual salary range for this role is $102,000–$178,000 USD. This range represents the compensation range for this role at the time of posting. The position is also eligible for bonus/incentive pay. Employees are eligible for a comprehensive package of benefits including paid time off, medical/dental/vision insurance, and 401(k).
Danaher Corporation and all Danaher Companies are committed to equal opportunity regardless of race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or any other legally protected characteristic.
We comply with federal and state disability laws and make reasonable accommodations for applicants and employees with disabilities. If a reasonable accommodation is needed to participate in the job application or interview process, to perform essential job functions, or to receive other benefits and privileges of employment, please contact 1‑202‑419‑7762 or
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