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Quality Engineer - Complaints (FDA regulatory requirements)

BaronHR Technical Irvine, CA
  • Expired: over a month ago. Applications are no longer accepted.

Our client located in Irvine, CA is looking for an Engineer II (Quality/Complaints Experience)

Long term contract
Pay rate $40-42 per hour

Our customer is the global leader in patient-focused medical innovations for structural heart disease, as well as critical care and surgical monitoring. Driven by a passion to help patients, the company collaborates with the world's leading clinicians and researchers to address unmet healthcare needs, working to improve patient outcomes and enhance lives.

Engineer II (Quality/Complaints Experience)
Duties: Complaints need MS office, Ignite, QMS

Perform complaint investigation on devices that are returned and on complaints where the device is not returned.
Work in the lab to perform visual inspection, measurements (dimensional), and functional testing where appropriate to determine root cause Review manufacturing documents, data, FMEAs, SOPs, and metrics as part of the investigation Author complaint evaluation reports for review and approvals.
Process the approved reports through company system.

Global Regulatory Authority Requests need MS office, QMS

Assess complaint data and metrics to respond to global regulatory authorities requests.
Draft response for review and approvals

Other projects and tasks

Process improvement projects
Drafting tech summaries for approvals

Education:
Bachelor's degree in Engineering or Scientific field is required plus a minimum of 2 years of applicable experience; OR Master's degree in Engineering or Scientific field plus applicable internship experience.

Required Skills:
BIOMEDICAL
FAILURE ANALYSIS
ROOT CAUSE ANALYSIS
INDUSTRIAL/MANUFACTURING
MEDICAL DEVICE
MS OFFICE
RISK ASSESSMENTS

BaronHR Technical

Why Work Here?

Temporary to direct position with one of the fastest no-startup growing companies in the country.

BaronHR Technical is a staffing firm specializing in both direct hire and contract/hire placements, with multiple divisions to meet your professional hiring demands. In today's fast paced and time sensitive environment where results are what matters, we provide customized services through our IT/Engineering, Accounting/Finance, Administrative & Operation divisions, which get you, our customer, the results you require. We provide a different approach to serving both the customer and candidates. For both we have the same philosophy: identify what is unique and distinct about a particular assignment or placement and work to create a "Win-Win" for all involved.

Address

Irvine, CA
USA

Website