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Lead Quality Assurance Engineer

2 months ago

Irvine, California, United States JobRialto Full time

Job Description:

Summary:

The primary role of a quality assurance engineer is to implement engineering concepts and methodologies to address challenges in industrial design or production processes.

A typical quality assurance engineer possesses the capability to create engineering schematics, draft risk assessment documents, and interpret technical drawings.

Job Responsibilities:


Utilizes expertise in quality assurance principles and techniques to ensure adherence to regulatory standards and company protocols, thereby enhancing product development, internal and external manufacturing, and distribution of devices.

Key Responsibilities:


Lead the identification, development, and refinement of intricate manufacturing processes through engineering methodologies (e.g., Six Sigma and Lean tools) aimed at optimizing design for manufacturing and ongoing process enhancement initiatives.

Recognize opportunities and implement strategies for the redesign of complex machinery, emerging technologies (including automation and software), tools, fixtures, etc., to enhance manufacturing workflows and mitigate overall process/product risk.

Supervise prototype assembly, train operators and inspectors, establish in-process inspections, validate inspection processes, manage defect categorization, etc.

Drive the formulation and oversee the execution of sophisticated experiments and assessments (including drafting and executing protocols) to create, validate, and enhance products (including evaluating source materials and suppliers) and establish robust manufacturing methodologies based on engineering principles; ensure thorough completion of comprehensive process validations (IQ/OQ/PQ), including analyzing outcomes and preparing reports; collaborate with cross-functional teams to ensure project success and timely completion.

Develop training and documentation resources for production (e.g., work instructions) to facilitate seamless knowledge transfer of project and manufacturing processes.

Generate technical content for risk management documentation.

Lead investigations into complex manufacturing product quality and compliance challenges (e.g., SCAR, CAPA, non-conformances, audit findings) for all supplier production processes, applying engineering principles; analyze findings, provide recommendations, and compile reports.

Mentor, coach, and guide junior employees on more intricate procedures.


Oversee quality support activities; instruct engineers/technicians on conducting tests; train engineers/technicians and provide constructive feedback; may coordinate the work of engineers/technicians.

Skills:

Creativity, strong verbal and written communication skills, analytical thinking, and problem-solving abilities.

Team-oriented and detail-focused.

Proficient in creating sketches, engineering drawings, and performing standard calculations.

Ability to read and interpret blueprints, technical drawings, schematics, and computer-generated reports.

Prior experience with engineering-related software applications, such as Computer Aided Design (CAD).

Education/Experience:
Bachelor's degree in engineering is required.

5-7 years of relevant experience is necessary.

Education: Bachelor's Degree.