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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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Quality
Engineer/Data
Analyst
Job
Description:
Reporting to the Director of Quality Assurance, the Quality
Engineer/Data Analyst’s primary responsibility is to collect
and analyze data and to recommend appropriate action steps for
performance improvement projects. This is accomplished through process
auditing and data collection; subsequent analysis and trending of data;
generating reports and presenting data to upper management; and working
closely with the members of Quality Assurance and Manufacturing
Operations to implement performance improvement projects. Ideal
candidates will flourish in an innovative, fast paced environment.
Responsibilities:
· Collect data through the
effective utilization of the Agile’s system and other
database systems.
· Manage databases to monitor
processes, outcomes, adverse events, and compliance with best practice.
· Conduct internal audits.
· Develop and implement
procedures for the identification, collection, and analysis of
performance measurement data.
· Continuously review and
monitor data. Identify and analyze trends of manufacturing processes
and outcomes, present data and analysis to upper management.
· Construct databases and
spreadsheets for data analysis.
· Use appropriate statistical
techniques to monitor product performance.
· Develop and facilitate
projects related to effectiveness (reducing errors and adverse events)
and efficiency (avoiding waste, improving throughput, reduce waits,
streamlining processes)
· Partner with project leaders
to develop team project plans, develop project scope, goals and
objectives, success criteria, assumptions, and interdisciplinary team
membership through rigorous analytical processes in collaboration with
project leader.
· Design data collection
methods and data analyses to support team efforts.
· Performs other related
duties as assigned.
Qualifications:
· BS degree (ME, EE, or
related discipline) and 0-2 years of experience in quality engineering
are required. Experience in Class II or III medical device
manufacturing environment highly desired.
· Must be familiar with
product verification & validation, process validation, supplier
quality control, MRB, and CAPA.
· Must be familiar with basic
statistics for trend analysis.
· Experience in Surface Mount
Technology (SMT), MIL-STD-883, MIL-STD-202, IEC-60601, IPC-A-610, and
design transfer required.
· Must be able to effectively
acquire information from cross-functional
groups.· Must have well
demonstrated written and verbal communication as well as presentation
skills.
· 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.
· Superior knowledge or
Microsoft Word, Excel, PowerPoint, and other software programs, as
needed.
· Ability to travel on
occasion, depending on project requirements.
If
you are interested in this postion, please visit our contact page here
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3401
Quebec St., Se. 3000 Denver, CO
80207 