Misco Jobs

Quality Engineer - Manufacturing/Medical Device/Quality/ISO 63-70 K/yr

Posted: 16 Sep 2009
Apply Deadline: 14 Dec 2009
Location: Milwaukee, WI, USA
Large OEM manufacturer just south of Milwaukee, Wisconsin is actively looking for an experienced Quality Engineer ( QE ) responsible for managing equipment and process validation.

Responsibilities:

-> Will direct equipment/process and validation IQ's, OQ's & PQ's for adherence to FDA QSR's
-> Will serve as leader of the CAPA program that determines root causes, corrective actions and follow through
-> Coordinate and improve quality in the areas of suppliers, gaging requirements and design
-> Performs internal audits to ensure quality compliance and develop calibration standards
-> Coordinate with suppliers and identifies areas for quality improvements
-> Assists with FMEAs

Requirements:

-> BS or MS Engineering Degree and 5+ years of Quality Engineering work experience
-> 3 years as a Quality Engineer with medical device experience in manufacturing operations and process qualification
-> Regulatory cGMP, QSR and ISO knowledge base
-> Experience in the area of manufacturing operations
-> Math aptitude: strong statistical skills required (DOE, SPC, Reliability, Gage R&R)
-> Computer literate/proficient with Word and Excel software programs and negotiation and problem solving skills
-> ASQ Certification a plus

Benefits:

-> Full Benefits to include
-> Medical
-> Vacation
-> and more
Questions you will be asked:

• Do you have a BS or MS Engineering Degree?

• Describe your overall Quality Engineering work experience. How many years?

• Briefly detail your experience as a Quality Engineer with medical device experience in manufacturing operations and process qualification. How many years?

• Discuss your experience with cGMP, ISO and statistical skills with (DOE, SPC, Reliability, Gage R&R).

• Where are you located now and how soon can you start?

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Contact Information:

Please mention Misco Jobs when applying to this position.

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