Misco Jobs

Quality Engineer - Quality Engineer/Medical Device/ISO 41-57 $/hr

Posted: 4 Oct 2009
Apply Deadline: 30 Dec 2009
Location: Round Lake, IL, USA
Immediate Need in Northern IL for a Quality Engineer. Contract Opportunity expected to last 6-9 months. There are 4 openings for this position. All positions require similar qualifications but have different roles within the Quality department. We are looking for QE's that have experience in Verification, Validation, Test, and Risk Management. All qualified candidates are encouraged to apply. Will Hire ASAP. Great Opportunity to get your foot in door with a global leader. Apply Now!

Responsibilities:

-> Provide guidance to product development teams as to the required deliverables to ensure compliance throughout product development cycle
-> For the Verification / Validation Test QE you will have to monitor and respond to quality questions or issues real-time during V&V test execution, this role covers the entire system including mechanical, electrical, and software
-> Review, assess and approve product design milestones and deliverables throughout product development cycle to ensure compliance
-> Assist Project teams to identify compliance risks during the product development cycle
-> Review and approve DHF and DMR documents and other records for the Quality function, including V&V, Risk Management, etc
-> For the Risk Management you will have to develop or review risk management documents and other records for the Quality function

Requirements:

-> 5-7 years working experience and understanding of product development in a medical device environment or regulated industry
-> Bachelor's Degree in Engineering
-> Must display a solid understanding of theories/practices utilized by other disciplines outside primary area of expertise
-> Strong knowledge of FDA, ISO, and MDD regulations, especially ISO 14971 for the Risk Management role
-> Ability to convince management on courses of action with minimal assistance using both written and verbal methods
-> Must be able to provide solutions that reflect understanding business objectives and cost implications
-> Effectively operate in and may facilitate cross-functional teams with minimal guidance

Questions you will be asked:

• What degree do you have?

• What area of Quality Engineering do you specialize in?

• Explain your experience within the medical device or regulated industry.

• When can you start?

• Where do you live, City and State?

Related Words: quality engineer, medical device, regulated industry, fda, iso, mdd, quality assurance, quality, qa, qc, statistical process control, spc, total quality management, tqm, process analyst, inspection, inspection, iso, taquchi, sampling theory, six sigma, six-sigma, 6 sigma, 6-sigma, sigma black belt, sigma black belts, master black belts, six sigma, six-sigma, 6 sigma, 6-sigma, sigma black belt, sigma black belts, master black belts, black belt, master blackbelt, master blackbelts, six sigma, six-sigma, 6 sigma, 6-sigma, sigma black belt, sigma black belts, master black belts, black belt, master black belt, master blackbelt, master blackbelts, green belt, mrp, spc, material resource, material management, mapics, bpics, apics, tqm, cim, jit, mtm, cim, mapics, bpics, apics, manufacturing, fabrication

Contact Information:

Please mention Misco Jobs when applying to this position.

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