Please send resume at wd_darshana at hotmail dot
com. Please indicate in the email how closely
the job description matches your background and
identify gaps, if any. Also, indicate your
current compensation and compensation expectations.
Quality Engineer with Injection Molding
Experience- Soquel, CA — permanent, full-time
Responsibilities: Write FEMAs, review and write
protocols and reports for new products; Be
involved with the design, procurement, validation
and qualification activities including test,
inspection and medical device contract
manufacturing service processes, Maintain
facility measurement equipment calibration
program; Collate and analyze manufacturing data
for warranty and nonconformance to determine and
report product quality trends; Conduct analysis
of inspection and tests of a routine degree of
complexity & provide recommendations; Develop
quality control inspection requirements &
techniques to achieve measured improvement;
Implement the Failure Analysis Process for
internal and external nonconforming product to
determine appropriate corrective action; Support
receiving, in-process and final inspection of
various components & subassemblies for medical
device products to support quality compliance &
shipment goals; Assist in development &
implementation of quality systems processes;
Attend product meetings with engineering, sales,
support, marketing, and customers to address
product requirements, customer concerns and
training issues; Work toward & support
Company/Department goals including QSR and ISO
compliance, revenues, training utilization,
customer satisfaction, and others as appropriate;
Qualify and implement document changes involving
product or process changes; Coordinate reporting,
analysis, & resolution of material
non-conformance incidences; Provide support in
the timely resolution of product complaints
and/or safety issues; Conduct quality audits and
develop subsequent preventive action programs;
Assist Regulatory Affairs Department in the
preparation of audits and reports for regulatory
agencies; Perform Supplier Quality Audits and as
appropriate Internal Quality System Audits;
identify root cause of non-compliance and ensure
timely/ effective corrections and/or corrective /
preventive actions are implemented; Drive
effective root cause corrective action through
internal and supplier surveillance and corrective
action requests; Report MRB performance metrics
and maintain corrective action database; Review
and report in-process data from manufacturing
processes and facilitate corrective and preventive actions.
Requirements: Bachelor of Science in Quality,
Business, Mechanical Engineering, or related
field, plus 5-7 years experience in Medical
Device Quality, Regulatory, or Manufacturing
environment is required. Also required, hands-on
manufacturing experience in mechanical or medical
device assemblies and working knowledge of
desktop computer office software, Visio Tools,
CAD software and e-mails. Experience as an ISO
Lead Auditor and working knowledge of US and
international medical device regulations,
desirable and CQE, CQA certification, a
plus. Experience with plastics and injection molding a HUGE plus.
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Potential applicants should communicate directly
with the contact listed in the posting. Please
do not "reply" to the posting messages.
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Received on 2013-04-23 14:19:30