Job: Quality Engineering Manager

Jobing Description

The Quality Engineering Manager is responsible for:

* Ensuring compliance to internal and corporate procedures, appropriate FDA and international regulations and standards through design of robust quality systems.
* Supporting the development and transfer of new products from the design phase to production and support enhancements to existing product lines.

Position Description & Requirements:

KEY JOB RESPONSIBILITIES:

* Plan, conduct, and direct quality engineering studies encompassing projects for the design/development validation of new or modified products/processes.
* Quality systems development.
* Lead in the development of appropriate inspection methods and sampling plans.
* Ensure quality of data interpretation.
* Plan, conduct, and direct the application of quality technology, including but not limited to FMEA s, DOE s, QFD s, SPC, and design control to projects, products, and processes.
* Review technical information for adherence to applicable regulatory requirements.
* Participate in cost reductions and profit improvement programs.
* Ensure compliance with company policies and business practices including FDA (Food & Drug Administration) regulations, GMP (Good Manufacturing Practices) and ISO (International Organization for Standardization) requirements.

EXPERIENCE:

* Bachelor degree in Engineering or Applied Science.
* 5 10 years experience in Quality Control.
* Experience in the medical device industry preferred.
* Minimum of 5 years previous supervisory experience, preferably in Quality Systems or Quality Assurance.
* Multi-disciplined Assurance background desirable.

Company Overview:

Smiths Medical is a leading global provider of medical devices for the hospital, emergency, home and specialist environments. Our products are used during critical and intensive care, surgery, post-operative care during recovery, and in a series of high-end home infusion therapies.

We offer 12 of the most respected and easily recognisable within our portfolio: Portex , Medex , Deltec , Level1 , Cozmore , Pneupac , Wallace , CADD , BCI , Jelco , Medfusion and Surgivet .

Smiths Medical is an equal opportunity employer.

If you require assistance with our online job submission process, please contact our Talent Acquisition team at 855-754-5032 to request an accommodation. Additionally, Smiths Medical invites interested deaf and hard of hearing applicants to use Video Relay Service (VRS).

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