Nobel Biocare Quality Engineer, Manufacturing (On-Site Yorba Linda, CA)

Envista Holdings Corporation•Yorba Linda, CA

2d•$105,200 - $128,600•Onsite

About The Position

The Quality Assurance Engineer ensures manufacturing processes remain controlled and that validation and verification activities are robust, so production consistently yields medical devices that meet specifications. The role supports compliant execution of New Product Introduction (NPI) and manufacturing Life Cycle Management activities, and drives continuous improvement. The position partners with Manufacturing Engineering, Operations, Engineering, and project teams on process controls, inspection and testing, standard work, change management, and quality documentation. It also supports audits, supplier audits, production issues, recalls, and corrective and preventive actions. The role provides guidance on applying internal and external procedures, standards, and regulations to maintain compliant documentation and practical quality processes.

Requirements

Bachelor's degree in Engineering, Life Sciences, or a related discipline.
At least 6 years of quality engineering experience in the medical device industry or an equivalent regulated industry in a manufacturing environment.
Hands-on expertise with root-cause analysis tools such as 5-Why and Fishbone, and Lean or Six Sigma methodologies.
Practical experience with risk management tools, including PFMEA.
In-depth understanding of applicable standards and regulations, including ISO 13485, ISO 14971, IEC 60812, and 21 CFR 820 QMSR.
Fluency in English.

Nice To Haves

Master's degree.
Independent work style and judgment in complex quality and compliance topics.
Risk-based thinking.
Effective verbal and written communication across functions.
Strong analytical, statistical, and documentation capabilities.
Objective problem-solving skills and the ability to make firm, risk-based quality decisions under pressure.

Responsibilities

Translate process risks into PFMEA controls, control plans, standard work, and appropriate in-process inspection.
Ensure validation and verification activities are robust and oversee revalidation cycles.
Ensure manufacturing-related procedures are strictly applied.
Partner with Manufacturing Engineering to optimize inspection and testing methods.
Participate in NPI and Lifecycle projects to ensure compliant execution.
Document, evaluate, and track production non-conformances, and lead or facilitate containment, root-cause analysis, NCR, and CAPA actions.
Use process, inspection, and nonconformance data to detect variation, confirm capability, and drive continuous improvement.
Partner with Operations and Engineering to follow standard work, manage changes, and maintain accurate, traceable records.
Support critical and time-sensitive topics, including recalls, production issues, internal and external audits, and corrective and preventive action.
Support the creation, implementation, training, and continuous improvement of Quality Assurance processes.
Advise project teams and individuals on applying and interpreting internal and external procedures, guidance, standards, and regulations, and on documenting activities appropriately.
Support internal and external audits.
Lead supplier audits.