At Abbott, diverse ideas, perspectives, and expertise allow us to create the life-changing solutions that help people live healthier lives. In 150 countries and with businesses spanning nutrition, diagnostics, medical devices, and branded generic pharmaceuticals, Abbott offers you enormous opportunities to explore your interests and help you achieve your career and personal goals.
Abbott Rapid Diagnostics (formerly Alere) is part of Abbott's Diagnostics family of businesses, bringing together exceptional teams of experts and industry leading technologies. We have an exciting opportunity for a Design Quality Engineer located at Pomona,CA. In this role, you will participate in in product development process and design transfer to manufacturing, ensuring product and process conformance to FDA Design Control, ISO 13485 and other applicable regulatory and technical standards.
Tasks and responsibilities:
* Support the implementation, maintenance and continuous improvement of quality management systems appropriate for a medical device manufacturing environment.
* Provide design assurance support in the design and development of medical device products, facilitating the application of design/change controls, risk management, and implementation of design and development plan.
* Responsible for effective transfer of product from development to manufacturing.
* Apply a risk based approach and appropriate statistical techniques consistent with FDA/ISO requirements toward assessment of design throughout development phases.
* Develop and execute validation plans, methods and protocols.
* Participate in Corrective and Preventative Action (CAPA) program, leading cross functional teams in root cause analysis of failures
* Support multiple projects, balancing priorities and resources to meet project and management expectations.
* Carries out duties in compliance with established business policies.
* Demonstrates commitment to the development, implementation and effectiveness of Alere Quality Management System per ISO, FDA, and other regulatory agencies.
* Responsible for exhibiting professional behavior with both internal/external business associates that reflects positively on the company and is consistent with the company's policies and practices.
* Understands and is aware of the quality consequences which may occur from the improper performance of their specific job. Has awareness of device defects that may occur in their area of responsibility, including product design, verification and validation, manufacturing and testing activities.
* Perform other duties & projects as assigned.
To be considered an applicant for this position you must show how you meet the basic qualifications of the job in a resume or document you upload, or by completing the work experience and education application fields. Accepted file types are Microsoft Word (DOC or DOCX), PDF, HTML, or TXT.
INTERNAL APPLICANT GUIDELINE:
* Please be advised that there is 5 calendar day window for internal employees to submit their applications and internal employees can not apply after 5 calendar day window is closed unless Hiring Manager requests to open the window again for more applications. * Before you apply for an internal opportunity you should notify your direct manager. * To be eligible for an internal transfer/promotion, you must be in your current position for at least a year and must maintain satisfactory performance in your current position and not be under a present corrective/disciplinary action.
Preferred Educational Background:
* Bachelor's Degree in engineering or related science.
Preferred Experiential Background:
* Minimum of 5 years' quality engineering experience in a regulated industry (IVD, medical device, pharmaceutical), with knowledge of product, process, and equipment validation.
* Comprehensive knowledge of FDA 21 CFR 820, ISO 13485 and ISO 14971 standards, and in particular, product design controls, development life cycle, risk assessment, and validation
* Good understanding of material and processes involving development and evaluation of reagents.
* ASQ Certified Quality Engineer
* Experienced in root cause investigation and tools
* Able to work with a variety of people on multiple tasks.
* Demonstrate problem-solving and troubleshooting skills
* Strong verbal and written communication skills
* Organized and detail oriented
* Knowledge and ability to use MS Office and other manufacturing systems