Quality Engineer Jobs

About The Position

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.

Benefits

• Medical, dental, and vision benefits.
• 401(k) match.
• Annual performance bonus may be included in the total compensation package.