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

Envista Dentistry•Yorba Linda, CA

1d•Onsite

About The Position

The Quality Assurance Engineer ensures production processes remain in a state of control, validation and verification activities are robust, and manufacturing consistently produces medical devices that meet specifications. The role supports compliant execution of New Product Introduction (NPI) and manufacturing Life Cycle Management activities, while driving continuous improvement. The position works with Manufacturing Engineering, Operations, Engineering, project teams and individuals to apply quality processes, manage changes, maintain traceable records, and interpret relevant procedures, standards and regulations. It also supports audits and time-sensitive quality matters, including recalls, production issues and corrective and preventive actions.

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 in root-cause analysis tools such as 5-Why and Fishbone, and in Lean or Six Sigma methodologies.
Practical experience with risk management tools such as 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 sound judgment in complex quality and compliance topics.
Ability to apply risk-based thinking.
Effective verbal and written communication skills across functions.
Strong analytical, statistical and documentation capabilities.
Objective problem-solving skills and 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 validations and verifications 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 help identify pragmatic approaches to compliant documentation.
Support internal and external audits.
Lead supplier audits.