Quality Engineer I

Position : Quality Engineer I (Complaint Investigations) / Complaints Engineer / Post-Market Surveillance Engineer / Quality Complaints Engineer, Req# : 8230-1

Location : Irvine, CA (100% onsite)

Duration : 6+ Months Contract

Job Description :

This team is looking for an eager-to-learn young engineer interested in quality engineering tied to complaints on medical devices.

This position is a Quality Engineer - Post Market Surveillance.

Perform customer complaints investigations, providing detailed analysis of the process and the data; determine root causes of the nonconformities to establish corrective and preventive actions.

Execute complaint investigations multifunctional approach and issues addressed in a systematic, methodical manner.

Oversight of all complaints that require investigation through the different phases.

Ensure on-time completion of complaints.

Work closely with complaint investigation owners to resolve issues and ensure those that have passed their due dates are addressed.

Ensure complaint investigations are adequate and comply with applicable procedures.

Applies knowledge of quality engineering principles and methods to ensure compliance with regulatory requirements and the client’s systems / procedures to optimize product development, internal and external device manufacturing, and device distribution.

Please refer to the job description for additional details.

Education and Experience :

Bachelor's degree in engineering, 0 - 2 years of experience related work experience required

Proficient with the Microsoft Office suite

Experience with medical device complaint investigations (CAPA's, NCR's, and Root-Cause Analysis)

Functional, physical, and visual testing of medical device equipment in a laboratory setting

Experience in medical devices (cardiovascular, endovascular, or other critical care / surgical products), healthcare, or a related environment preferred.

Experience in complaint investigations, root cause analysis, and the associated risk assessments preferred.

Preference is for candidates to have some complaint investigation experience / root cause analysis. Another preference is for medical device experience.

Additional Skills :

Good documentation, communication and interpersonal relationship skills including negotiating and relationship management skills

Basic understanding of statistical techniques

Previous experience working with lab / industrial equipment required

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 Quality systems

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 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 the environment and prevention of pollution under their span of influence / control with computer applications and software related to engineering field, such as Computer Aided Design (CAD).

Roles and Responsibilities :

Investigate moderately complex manufacturing product quality and compliance issues (e.g., CAPA, non-conformances, audit observations) for all production processes before final product release based on engineering principles;

analyze results, make recommendations and develop reports.

Optimize to optimize moderately complex Manufacturing processes using engineering methods (e.g., SIX Sigma and LEAN methods) for design for manufacturing and continuous process improvement.

Identify opportunities for re-design / design of basic equipment, tools, fixtures, etc. to improve manufacturing processes, and reduce risk

Develop, update, and maintain technical content of risk management files

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

Assign support tasks; give instruction to technicians on conducting tests; trains technicians and provide feedback; and coordinate technician work.

Other incidental duties assigned by Leadership

TB EN