Manager, Quality Engineering Operations

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.

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Want to lead a hands-on Quality Assurance team that drives operational excellence and technical problem-solving in a fast-paced manufacturing environment

The Manager Quality Engineering Operations is responsible for responsible for leading a team of QA Engineers and Technicians to ensure product and process quality across manufacturing operations and maintaining a full QMS compliant to the site specific ISO 9001 certificate including managing audits by regulatory authorities and customers.

This role focuses on technical troubleshooting process validation equipment qualification and supplier quality engagement. Youll have opportunities to lead continuous improvement projects collaborate with cross-functional teams and make a direct impact on operational performance.

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:

• 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.

The essential requirements of the job include:

• Bachelors 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.

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

• 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.

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 for this role is $USD. 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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