Sr. Hardware Design Quality Engineer

Sr. Hardware Design Quality Engineer page is loaded## Sr. Hardware Design Quality Engineer locations:
United States - California - San Diegotime type:
Full time posted on:
Posted Todayjob requisition :
Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 114,000 colleagues serve people in more than 160 countries.##
*
* JOB DESCRIPTION:

** Job Description
** About Abbott
** Abbott Rapid Diagnostics is part of Abbott’s Diagnostics family of businesses, bringing together exceptional teams of experts and industry leading technologies to support diagnostic testing which provides important information for treatment and management of diseases and other conditions.

The position of
** Senior Design Quality Engineer
** is within our Infectious Disease Developed Markets business unit located at Scarborough, Maine. In this role you will actively participate in product development and transfer activities, ensuring product and process conformance to FDA and ISO 13485 standards. This position will review validation methods and protocols, test methods, statistical analysis methods and specification derivation and assignment. Review new and modified product designs for quality characteristics;

including manufacturability, serviceability, and conformance to product requirements. The position is responsible for training other Design Quality Engineers and Quality Assurance personnel in Design Controls and Risk Management. This role requires strong communication, interpersonal and organizational skills, and a solid understanding of the application of FDA, ISO 13485, and ISO 14971 standards.

If you seek a dynamic role where your contributions will pave the way in developing new products, systems, and processes, come work with us!

This job description will be reviewed periodically and is subject to change by management.
** WHAT YOU’LL DO
*** Represent the Quality function to provide design assurance support in the design and development of medical device products and facilitate the application of design controls and risk management.
* Providing training and guidance to other Design Quality Engineers and Quality Assurance professionals on new product development and change processes.
* Act as a reviewer and approver of validation methods and protocols, test methods, statistical analysis methods and specification development.
* Review new and modified product designs for quality. Ensure that product development projects and changes to existing products are conducted in compliance with the FDA Quality System Regulation and other global regulations.
* Act as a key contributor to development and validation plans and processes.
* Act as a key team member in establishing, communicating and mitigating risks.
* Ensure successful transfer of new products to manufacturing.
* Review design history files and technical files for conformance to applicable requirements.
* Support the continuous improvement to the Quality Management System, with a specialty focus on design controls and associated processes.
* Identify and propose remediation for existing and potential quality issues; act as project team quality solution provider to maintain compliance.
* Provides leadership in all areas of the Quality System, including but not limited to design controls, risk management, etc.
* Provides leadership in the understanding of FDA and applicable non-US regulations pertaining to medical or pharmaceutical manufacturing, including hardware, software, and bioassay systems.
** EDUCATION AND EXPERIENCE YOU’LL BRING
**** Required
* ** Bachelors’ degree (B.S.) in a Science related field, or equivalent combination of education and experience
* 5+ years related experience and/or training in a Quality and/or Development Position.
* Significant experience in risk management throughout the product lifecycle, including a strong working knowledge of ISO 14971
** Preferred
* ** Experience supporting ISO 13485 inspections and FDA inspections.
* Working…