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Scientific. Clinical. Software Engineering

Quality Engineer II

Orange County Metro Area, CA

Job Type: Engineering Job Number: JN -112020-27641 Region: Orange County Metro Area

Job Description

Quality Engineer II New Product Development

Lifesciences Industry

Irvine, CA


Job Description & Qualifications


Applies knowledge of technical principles and our systems/procedures to develop new products.


Key Responsibilities:


Develop risk management documentation including risk management worksheet and FMEAs

Collaborate with R&D to develop design requirements and support feasibility, design verification and validation testing including writing and executing protocols, analyzing results and developing reports and technical summaries

Support test method development and validation activities for new designs including writing test method procedures, developing and executing protocols for test method validation

Support failure investigations for product failures in design testing and clinical use

Support development and implementation of inspection and testing mechanism for components, sub-assemblies, and final assemblies used in new product design and manufacturing

Ensure compliance with all Federal, State, local and company regulations, policies and procedures.

Performs other quality-related duties as assigned by management


Required Education & Skills:


Bachelor s Degree in Engineering or Scientific field with a minimum of two (2) years related experience required; OR a Master s Degree in Engineering or Scientific field.

Good documentation, communication (e.g., written and verbal) and interpersonal relationship skills including consultative and relationship management skills

Basic understanding of statistical techniques

Solid understanding and knowledge of principles, theories, and concepts relevant to Engineering

Solid problem-solving, organizational, analytical and critical thinking skills

Solid understanding of processes and equipment used in assigned work

Knowledge of and adherence to Edwards Environmental Health and Safety and Quality guidelines as they relate to department clean room medical device manufacturing

Knowledge of applicable FDA regulations for medical device industry

Strict attention to detail

Ability to interact professionally with all organizational levels

Ability to manage competing priorities in a fast paced environment

Must be able to work in a team environment, including the ability to manage vendors and project stakeholders

Ability to build productive internal/external working relationships

Adhere to all EHS rules and requirements and take adequate control measures in preventing injuries to themselves and others as well as to the protection of environment and prevention of pollution under their span of influence/control

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