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 Sr. Design Quality Engineer located at Pomona, CA. In this role, you will report to the Quality Director and actively lead QA support for the product development process and design transfer to manufacturing, ensuring product and process conformance to FDA Design Controls, ISO 13485:2016, ISO 14971:2012 and other applicable regulatory and technical standards.
* Lead design quality assurance support in the design and development of In-Vitro Diagnostics (IVD) medical device reagent products, facilitating the application of design/change controls, risk management, quality plan and implementation of design and development plan. * Lead, create and maintain risk management files such as UMFMEA/DFMEA/PFMEA that identify Hazard Analysis Critical Control Points (HACCP) and are compliant with the requirements of ISO 14971:2012. * Work closely with R&D, Manufacturing, Quality Control, and Applications Support management to prevent non-conformities and provide solutions to complex issues. * Lead and support multiple projects, balancing priorities and resources to meet project and management expectations. * Other duties 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.
Education and Experience Requirements:
* BS/BA in field of Science such as Chemistry, Microbiology, Biology, Biochemistry or Engineering. * Minimum of 7 years of design Quality Assurance engineering experience (design controls and risk management) in a reagent manufacturing environment with In-Vitro Diagnostics (IVD) Medical Device. * Minimum of 5 years hands-on risk management experience in creating and maintaining risk management files such as UMFMEA/DFMEA/PFMEA, Plans, Reports, etc. * Hands on Design Verification and/or Design Validation/Process Validation experience helpful. * Hands on Design History File (DHF) assessment, Design History Record (DHR), and Design Master Record (DMR) analysis experience helpful. * Hands on CAPA System, Non-conformity System and manufacturing process improvement experience. * Process, QMS or Supplier auditing experience preferred. * Lean Six Sigma (Black or Green Belt), Certified Quality Engineer, Certified Quality Auditor desired.
* Knowledge of IVDR in EU, FDA QSRs, ISO 13485:2016, ISO 14971:2012 standards and HACCP, GMP, GLP and GDP requirements. * Experienced in root cause investigation and tools. * Goal oriented, learns quickly, works in a collaborative manner with other departments. * Good writing and verbal communication skills. * Knowledge of computers and software programs including Word, Excel, Access, Visio, MS Project, Minitab, PowerPoint and Agile.
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 103,000 colleagues serve people in more than 160 countries.
Connect with us at www.abbott.com, on LinkedIn at www.linkedin.com/company/abbott-/, on Facebook at www.facebook.com/Abbott and on Twitter @AbbottNews and @AbbottGlobal.
An equal opportunity employer, Abbott welcomes and encourages diversity in our workforce.
We provide reasonable accommodation to qualified individuals with disabilities. To request an accommodation, please send an email to ...@alere.com.