Quality Engineer I
Roth Staffing Companies

Our Medical Device Client is seeking a Quality Engineer for their team in Irvine, CA!

Quality Engineer

Duration - 3+ Months, Contract, W-2

Location - Onsite in Irvine, CA

Pay - $35 - 41 an hour

Job Description:

• This position is on the Quality Engineering team responsible for leading and performing critical engineering investigations on globally reported complaints for returned/non-returned devices.

• Ensure compliance with regulatory requirements and systems/procedures for device investigation and risk assessments of reported complaints from the field.

• 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 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 determination by 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).

Education and Experience:

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

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

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

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 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

All qualified applicants will receive consideration for employment without regard to race, color, national origin, age, ancestry