Quality Engineer I

4 weeks ago

Irvine, United States LEDGENT Technology & Engineering - Roth Staffing Companies, L.P. Full time

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

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