Design Quality Engineer - Clinton, PA

Design Quality Engineer - Clinton, PA page is loaded## Design Quality Engineer - Clinton, PA locations:
Clinton, PAtime type:
Full time posted on:
Posted Todayjob requisition :
R10068

We are constantly looking to add to our core talent. If you are seeking a career that is challenging and rewarding, a work environment that is diverse and dynamic, look no further — Haemonetics is your employer of choice.## Job Details#
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* Job Summary:

** Support the quality system by ensuring compliance to and enforcing regulations, standards, policies, standard operating procedures, and instructions related to design control of Haemonetics products. Effective member of assigned cross-functional design teams supporting new product development and sustaining engineering change management.#
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* Essential Functions:

** SUPPORT NEW PRODUCT DEVELOPMENT & PRODUCT CHANGE MANAGEMENT PROJECTS BY:
* Represent Quality department as cross-functional team member for product portfolios, new product development projects, and product change projects
* Support detail tracking through project deliverables such as project quality plans and safety assessments and perform updates and release to documents within the electronic system
* Participate in:  + Translation of Voice-of-Customer into development Requirements  + Development, update, and release of various risk management documentation
* Support development team in the creation, review, and approval of:  + Engineering Requirements & Specifications  + Engineering test protocols and reports required for design verification, design validation
* Define statistical sampling and testing methods required for verification and validation testing and provide measurement analysis support as required
* Ensure accuracy and completeness of the Design History File and the Device Master Record
* Ability to support multiple Product Line Portfolios
* Provide quality engineering support for process development, implementation, improvement and validation efforts as assigned
* Provide Post Market Surveillance complaint investigation technical support

SUPPORT QUALITY SYSTEM BY:
* Leading or participating in continuous improvement projects as well as improvements to policies, procedures, instructions, and training
* Ensuring the ongoing readiness of the Quality Management System for external and internal audits and participating in audits and inspections as required
* Ensuring compliance to and enforcement of applicable regulations, standards, Haemonetics policies / procedures#
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* Qualifications:

*** Minimum of 3 years medical device or IVD product development and design quality engineering experience
* B.S. in Biomedical, Mechanical, Electrical or other appropriate Engineering degree.
* Good working knowledge of medical device design control process including risk management and design transfer
* Strong team collaboration with ability to handle multiple tasks in a fast pace new product introduction environment.
* Manufacturing process validation knowledge and experience
* Familiar with medical device Quality Management Systems
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