Quality Engineer

Position: Quality Engineer II (Complaint Investigations), Req : 6085-1

Location: Irvine, CA (100% onsite)

Duration: 3 Months Contract

Job Description:

This position will be in THV Quality Engineering, Global Product Surveillance (GPS). The GPS team is responsible for leading and performing critical engineering investigations on globally reported complaints for returned/non-returned devices. The role is not remote and will require a presence on campus.

This opening is with the THV quality engineering team. The team of 23 engineers and technicians handles about 80 to 100 complaints per week. As a member of this team, you will have the opportunity to interact with domestic and global medical teams/clients.

Applies knowledge of quality engineering principles and methods to ensure compliance with regulatory requirements and the client's systems/procedures for device investigation and risk assessments of reported complaints from the field.

Education and Experience:

Bachelor's Degree or equivalent in Engineering or Scientific field, 2 years of experience related to work experience required; or Master's Degree or equivalent in Engineering or Scientific field, 1-year experience including either industry or industry/education 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 project stakeholders

Ability to build productive internal/external working relationships

Roles and Responsibilities:

Investigate complex manufacturing product quality and compliance issues reported from the field, analyze results, determine root cause/probable cause, and initiate and review reports.

Perform hands-on device investigation using visual, dimensional, and test equipment to determine the root cause.

Assess reported events against established risk documentation for clinical and compliance risk(s) and escalate to Quality Management and Product Safety as needed.

Participate in escalation tasks and activities, including Project Risk Assessments (PRA) and Corrective/Preventive action(s) - CAPAs, SCARs, as determined by the investigation.

Identify and report key complaint metrics per device category and collaborate with applicable manufacturing engineering teams to resolve production/device-related issues.

Other incidental duties assigned by Leadership (May assist in Adhoc complaint analysis or metric review).

TB EN