Position Title:Software Quality Assurance Engineer
Location: San Diego,CA or Pomona,CA
DO WORK THAT MATTERS:
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 Software Quality Engineer within our Toxicology Business Unit. The position will be located at a Toxicology entity in San Diego, CA or Pomona, CA with travel to other Toxicology locations.
Responsible for identifying, leading, and/or supporting quality, regulatory, and compliance improvement initiatives, projects, and remediation activities at site, cross-site, and Business Unit levels. Position will focus on assessing, validating, implementing and deploying effective software solutions to support regulated activities across the Toxicology Business Unit.
* Reporting to the Sr. Manager, Toxicology Quality Systems, supports the development, implementation, improvement, and/or effectiveness of Quality Systems in compliance with applicable ISO, FDA, and other regulatory agency regulations and standards through implementation of effective software solutions.
* Uses strong technical skills to develop, modify, apply & maintain processes for software system qualification at toxicology manufacturers, distributors and laboratories.
* Conducts evaluation and develops improvement strategies of software system activities including requirements, design, development, documentation, verification and validation while incorporating best practices and risk mitigation techniques.
* Supports the effectively deployment of enterprise e-tools at various Toxicology entities.
* Manages assigned cross-site data collection, evaluation, and analysis related to Software Quality and reports results to site and/or Business Unit leadership. Provides, and may execute, suggested remediation activities.
* Works directly with entities in establishing compliant validation and verification protocols for software tools.
* Assists internal and external audits as assigned.
* Carries out duties in compliance with established business policies.
* 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 and 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.
* B. Eng or B.Sc in software engineering, computer science or related field.
* Ability to travel up to 25-50% of time to different Toxicology entities. The majority of travel will be domestic but ability to obtain a passport for international travel is required.
* Minimum of three to five years of experience in the medical device industry or related industry with exposure to quality and manufacturing processes. Has an in-depth understanding of quality management systems, manufacturing processes, and software qualification regulations.
* Industry experience in qualification of software systems.
* Strong analytical, written, and verbal communication skills and the ability to articulate complex quality and regulatory matters with persons of a variety of backgrounds.
* ASQ Certification or equivalent is beneficial.
* Effective organizational and time management skills.
* Must have capability to review, analyze, summarize and interpret quality systems data, draw conclusions, make appropriate decisions and recommendations, write reports and give oral presentations.
* Must show strong self-initiative and be comfortable in the role of a team player. Must be able to work independently with minimal supervision.
Please note that candidates need to be eligible to work in the U.S. without Abbott sponsorship.
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 firstname.lastname@example.org.
Alere provides diagnostics and health management solutions for infectious, heart and cancer-related diseases and drug addicts.