MicroVention, Inc

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Sr. Quality Engineer - Production Support

at MicroVention, Inc

Posted: 7/2/2019
Job Reference #: 442260
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Job Description

Title
Sr. Quality Engineer - Production Support

Job Description
INNOVATION STARTS WITH YOU
 
Are you interested in working for an organization that is making a difference in people’s lives every day?  We’re a medical devices company that develops innovative neuroendovascular technologies for the treatment of vascular disease.  We’re a high-growth, customer-focused company with an entrepreneurial spirit producing some of the most reliable and technologically advanced products supported by proven clinical data.  Take a closer look at what 
MicroVention® TERUMO has to offer.

Sr. Quality Engineer, Production Support

Position Overview
The Sr. Quality Engineer, Production Support will support the manufacture of medical devices.  Will work with Manufacturing and R&D Engineering teams to support manufacturing process changes, resolve product quality issues, and support the implementation of new products.  Job duties: 
  • Works with Manufacturing Engineers on process improvement and cost reduction projects.
  • Resolves product quality issues and manages non-conformance investigations and corrective actions.
  • Leads / manages QAR / CAPA projects as assigned.
  • Works with Supplier Quality Manager / Engineers to maintain high quality level of incoming production materials.
  • Supports process validation by developing or reviewing test protocols and reports.
  • Supports equipment qualifications by reviewing equipment specifications, IQ / OQ reports and unscheduled maintenance reports.
  • Supports internal and external audits by participating preparation activities and addressing audits findings.
  • Works with R&D, Manufacturing Engineers, Regulatory, and Supply Chain Planner to support implementation of new products on Production floor.
  • Works with R&D and Manufacturing Engineers to develop and update pFMEA based on non-conformance reports and complaints.
  • Works with Manufacturing Engineers to perform product quality metric data analysis.
  • Leads projects in improving effectiveness and efficiency of assembly inspection activities and cross-functional system-related processes.
  • Performs other duties and responsibilities as assigned.


Auto req ID
7417BR

Location
Aliso Viejo, California, USA

Department Name
321-Production Support Quality Assurance

Qualifications
  1. Bachelor’s degree in Engineering or equivalent.
  2. Six (6) or more years of engineering experience in medical device manufacturing industry.
Desired Qualifications
  1. Ability to understand the technology related to MicroVention’s products.
  2. Knowledge of medical product quality assurance (including the requirements for test protocols, test reports, and statistical techniques).
  3. Computer skills including MS Word and Excel, with the ability to learn Statistical Software (MiniTab, Statgraphic, Design of Experiment DOE).
  4. Good interpersonal and communication (orally and in writing) skills.


External-Facing Title
Sr. Quality Engineer - Production Support

Posting Country
US - United States