Quality Engineer

2 weeks ago

Irvine, United States Motion Recruitment Full time

Title: Engineer-2 (Quality)

Location: Irvine, CA

Duration: Contract


About the Client:

Join a distinguished member of the Fortune 100 community, specializing in cutting-edge medical devices tailored for critical care, structural heart interventions, and surgical monitoring. With a rich heritage built upon values of integrity, collaboration, and relentless innovation, our partner stands at the forefront of revolutionizing healthcare. Key offerings include transcatheter heart valves, innovative transcatheter mitral solutions, advanced critical care monitoring systems, and state-of-the-art surgical valve technologies.



Overview:

The main function of the Quality Engineer is to lead all software engineering activities relating to the validations of several production equipment with custom software. The main purpose of this role is to apply knowledge of software quality engineering to assess risk, execute validation activities and develop/approve software documents.


Job Responsibilities:

• Investigate complex product / non-product software quality and compliance issues (e.g. software deviations/failures) for all production processes prior to final product release based on engineering principles; analyze results, make recommendations and develop reports.

• Assess Risk Management activities including authoring of Software Hazard Analysis for complex projects / systems / test equipment in partnership with cross-functional teams; provide recommendations for improvements.

• Develop complex software documentation (e.g. Protocols, Reports, Hazard Analysis) for product or non-product software validation deliverables utilizing engineering knowledge.

• Collaborate with stakeholders on the Code Review process for product software or custom manufacturing test equipment.

• Perform dry-runs and execution of Software Validation Protocols.

• Train, coach, and guide other employees on software documentation.

• Other Incidental duties as required.


Required Skills:

• Proven expertise in usage of MS Office Suite;

• Strong documentation, communication and interpersonal relationship skills including negotiating and relationship management skills.

• Working knowledge and understanding of statistical techniques.

• Substantial understanding and knowledge of principles, theories, and concepts relevant to Software Development Lifecycle related to Software Quality Engineering (e.g., CQE body of knowledge) for product and non-product software.

• Substantial knowledge of business acumen products and software technologies

• Strong problem-solving, organizational, analytical and critical thinking skills

• Substantial understanding of processes and equipment used in assigned work

• Good leadership skills and ability to influence change

• Knowledge of and adherence to related procedures (e.g., Cybersecurity procedures related to IT systems, manufacturing equipment or product software).

• Strict attention to detail

• Ability to interact professionally with all organizational levels

• Ability to manage competing priorities in a fast paced environment

• Adhere to all company rules and requirements (e.g., pandemic protocols, Environmental Health & Safety rules) 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


Level of Independence:

• Works independently without close supervision.

• Compares and evaluates possible courses of action after considering various possibilities.

• Applies knowledge in following procedures or in determining which procedures to follow or determining whether specified standards are met.

• Considers the cause and effect of activities.

• Determines or effectively recommends course of action after considering potential risks of alternatives.

• Makes decisions in the face of different alternatives and without formulas or guidelines or with guidelines that are not complete and exhaustive.


Education/Experience:

• Bachelor's degree in engineering required.

• 2-4 years experience required.

• Previous experience with software verification and validation activities in a medical device industry.

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