Quality Engineer - Medical Devices

The Quality Engineer functions as a project core team member, representing Quality Management on new product development projects, committing to support product / project objectives, driving and participating in business decisions, and assuming accountability for product / project success. The Quality Engineer also serves as an interface between a cross-functional extended core team and the project core team leader on new product development projects.

The position works under supervision on technical quality related tasks, provided with techniques and procedures, applying judgment to details of work and in making preliminary selections or adaptations of quality alternatives. The position develops realistic action steps, timetables and resource estimates for global or plant projects, and may work as project lead on smaller projects. The position also supports quality management in establishing goals and strategies, and implements quality projects and reviews the results with appropriate customers.

Responsibilities

* Facilitate project quality planning activities addressing design and process verification / validation for new products and significant changes to existing products or processes.
* Guide cross-functional teams in the appropriate application of design controls in compliance with global regulatory requirements for medical devices.
* Facilitate design FMEA, participate in process FMEA, and conduct risk assessments in compliance with ISO 14971.
* Interface with Hollister plant and supplier Quality Engineering and Quality Assurance for new products and significant changes to existing products or processes.
* Utilize parametric and nonparametric statistical analysis methods (ANOVA, DOE, hypothesis testing, power analysis, process capability analysis, quality control charts, regression analysis, survival analysis, measurement system analysis, acceptance sampling ANSI/ASQ Z1.4 & Z1.9) to ensure products / processes are appropriately characterized and qualified prior to market release.
* Support review of Preproduction and First Article submissions from the plants and suppliers for new products and significant changes to existing products or processes.
* Support the corporate facility quality management system.
* Participate in internal, supplier, and external regulatory agency audits / inspections as required.

Experience

* 3 + years experience within Quality Engineer within the Medical Device field
* Technical degree
* Knowledge of Product Development
* Knowledge of statistics, design controls, risk management

Nice to have

* Any ASQ Certifications
* Experience in New Product Development
* Further relevant education and training

If you're interested, please send your resume to Quality Engineering specialist Christopher Atiyah or call on 312 453 9077.To find out more about Real Staffing please visit www.realstaffing.com