Quality Engineer
Company: Cypress HCM
Location: Santa Ana
Posted on: February 17, 2021
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Job Description:
We have an exciting opportunity for a Quality Engineer position
with one of the top medical device companies in the country. This
position will provide risk management activities including
planning, assessment, quantification, implementation of risk
control measures, and effectiveness within an ISO regualted
environment. Responsibilities:* Development, application, revision,
and maintenance of documentation for design control and processing
materials into partially finished or finished products, inspection
and process development, qualification of equipment, validation of
processes, including test method and some level of software
validations. * Provides quality assurance support to the company
Manage or assume functional responsibility for bigger projects or
multiple smaller projects. * May supervise other Engineers, or
manage other resources (external partners, contracts, budgets, etc)
May have some type of Financial Responsibilities: cost center and
capital purchases Demonstrate project ownership and accountability
for project results * Develop working relationships outside of
department, cross functionally. * Think strategically as it
pertains to a given project. * Demonstrated effective negotiation
skills and can work through obstacles effectively * Develop or
assist in design verification activities (protocols and reports) *
Develop and execute design validation activities (protocols and
reports) * Develop and execute process validation protocols and
reports for manufacturing, inspection, or test equipment * Develop
and validate measurement method; software validation capability a
plus. * Respond to internal CAPA and QA audit findings support
developmental projects Qualifications * Bachelors degree within
engineering or science required * ASQ Certified Quality Engineer or
Six Sigma Black Belt preferred * Knowledge of quality assurance
practices within the medical device industry, including FDA Quality
System Requirements (QSR) and ISO 13485 DMAIC problem solving and
analytical skills * 25% Travel
Keywords: Cypress HCM, Santa Ana , Quality Engineer, Engineering , Santa Ana, California
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