US: Quality Engineer
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please visit http://sqa.fyicenter.com
Perform drawing review for new and/or revised drawings.
Create/revise Inspection Plans as required.
Perform Tooling QA contract review.
Perform first time production order contract review.
Create qualification protocols for processes and equipment.
Review FA and Qualification results. Initiate corrective actions as necessary.
Prepare qualification reports for approval
Maintain Internal Audit system.
Identify opportunities for improvement and participate in improvement projects.
Monitor quality goals/metrics and report on status.
Other tasks as directed by management.
Effective verbal and written communication skills.
Ability to multitask.
Working knowledge of Microsoft Excel (including formulas and charting) and Minitab software.
Thorough understanding of qualification requirements (IQ/OQ/PQ) for the medical device industry.
Ability to understand and analyze capability studies and determine required actions, as necessary.
Ability to read, understand and implement recognized sampling plans appropriate for Reny’s manufacturing.
Blueprint reading and understanding of Geometric Dimensioning and Tolerancing.
Be accurate and attentive to detail.
Ability to assist and support others.
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Team SQAFYI - Software QA Resource FYI