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"Honesty,
Integrity and Reliability" -- The traits we value most in our
customers,
clients and most importantly – Ourselves
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Senior
Quality Engineer [Medical Device]
Job
Description:
The Sr. Quality Engineer is responsible for ensuring that the
components, processes and our fully implantable finished products are
designed, built, documented and inspected to meet the required
standards. Ideal candidates will
flourish in an innovative, fast paced
environment.
Responsibilities:
· Responsible for developing,
applying, revising and maintaining quality standards for processing
materials/products into finished products.
· Designs and implements
methods and/or procedures for inspecting, testing and evaluating the
precision and accuracy of products and/or production
equipment.· Analyzes returned
products and recommends corrective action.
· Capable of performing Design
Review, Risk Analysis and Management, Design FMEA and Process FMEA.
· Capable of developing
Quality Plan, Product Validation Plan, and Product Shelf Life Study
Plan/· Prepares documentation
for inspection/testing procedures.
· Receives technical guidance
on unusual or complex problems and supervisory approval on proposed
plans for projects.
· Plans, schedules, conducts,
and coordinates detailed phases of engineering work in part of a major
project or in a total project of moderate scope.
· Performs work which involves
conventional engineering practice but may include a variety of complex
features such as conflicting design requirements, unsuitability of
conventional materials, and difficult coordination requirements.
· Performs other related
duties as assigned.
Qualifications:
· BS degree (ME, EE, or
related discipline) and 6-8 years of medical device experience in QA
required. Experience in Class II or III medical device
manufacturing environment highly desired.
· Must have experience in
product verification & validation, process validation, supplier
quality control, MRB, and CAPA.
· Must be familiar with basic
statistics for sample size selection, SPC QSR, ISO 13485, & ISO
14971.
· Ability to work
independently and effectively in a small team environment.
· Must be well-organized,
detail-oriented and able to handle and effectively prioritize multiple
tasks.
· Well-demonstrated written
and verbal communication skills.
· Good working knowledge or
Microsoft Word, Excel, PowerPoint, and other software programs, as
needed.
· Ability to travel on
occasion, depending on project requirements.
Preferred
Experience:
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Experience in Risk Analysis and Risk Management.
· Experience in Surface Mount
Technology (SMT), MIL-STD-883, MIL-STD-202, IEC-60601, IPC-A-610, and
design transfer required.
If
you are interested in this postion, please visit our contact page her |
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3401
Quebec St., Se. 3000 Denver, CO
80207 