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Software Quality Engineer

Abbott Charlottesville Full-Time
$112,080.00 (Careerbuilder est.)
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SOFTWARE QUALITY ENGINEER
Charlottesville, VA

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 Quality Engineer (QE) is within our ARDx Informatics business located at Charlottesville Virginia. This role will be responsible for global quality engineering activities through participation and quality oversight of software product development, commercialization and sustaining activities. The primary scope is software quality assurance with the aptitude to apply knowledge and skills to quality oversite within the Quality System activities. The QE receives general direction and exercises considerable discretion as to work details. Responsible for own documentation, and for its accuracy, quality, and timeliness. As a member of a cross-functional team, the QE ensures quality objectives are met, they are compliant with site level policies and procedures, aligned with the quality system and consistent with regulatory requirements and business objectives.

This job function has accountability for complying with the applicable elements of Global Quality and the ARDx Quality Management System (QMS)

RESPONSIBILITIES:
  • Participate in global quality engineering activities in software product development, manufacturing, and support including engineering design review, verification/ validation activities.

  • Able to defines design document requirements for process and test method validation within Design Control and Software Development Life Cycle (SDLC). Reviews and approve software lifecycle deliverables.

  • Directly influences project direction and scope, guides product development teams through design validation and regulatory compliance and assures robust product vs. customer requirements.

  • Applies established quality and engineering methods to the investigation and solution of software quality problems. Performs CAPA (Corrective Action Preventive Action) and FCA (Field Corrective Action).

  • Participates, through the creation and review of improvements of software development, software processes, and documentation processes.

  • Supports supplier qualification and maintenance activities. Performs SCAR (Supplier Corrective Action), and process deviation activities.

  • Participate in internal audits.

  • Understands and assesses the impact of a change on the safety and efficacy of a software product, device, process performance, and internal/external customer expectations worldwide.

  • Participates in Risk Management activities. Assesses internal and external risks associated with specific actions, quantifies risks, seeks input from others, and idenifies actions to limit the exposure of the division.

  • Supports non-product software lifecycle activities including review and assessment of software activities (suppler evaluations, validation, lifecycle deliverable documents) to ensure compliance with applicable procedures, standards and regulatory requirements.

  • Participates in multi-site and business wide software lifecycle activities to accomplish quality system objectives.

  • Investigates and analyzes impact of failure within and across product lines. Uses technical, compliance, product and process knowledge to assist in identifying preventative actions. Able to assure effectiveness of actions are taken to prevent reoccurrence.

BASIC QUALIFICATIONS | EDUCATION:
  • 4 year degree in a scientific or technical discipline preferred or 10+ years of experience in a related field.

  • 1-3 years in a regulated environment, preferably in medical devices with excellent understating and knowledge of quality system processes.

  • Use of analytical skills and ability to organize work in a logical and thorough manner.

  • Capable of analyzing data to support the development of strategies to effectively manage, enhance, mitigate, and/or resolve potential issues.

  • Challenges data adequacy based on experimental design concepts. Recognizes when issues may have an impact on areas outside of their immediate area of responsibility.

  • Highlights issues in a timely manner and presents possible resolutions. Seeks additional information when problem is beyond area of personal expertise.

  • Experience in reviewing, and executing validation and change control documents, authoring SOPs, Protocols (IQ, OQ, PQ) of Process Control Systems

  • Demonstrates project management skills.
  • Possesses interpersonal skills to negotiate and reconcile differences.

  • Flexibility to adapt to changing assignments and ability to effectively prioritize.


PREFERRED QUALIFICATIONS:

  • Advanced understanding of compliance, cGMP and software development and validation. Able to relate information to product specifications product claims and design.

  • Able to prepare, analyze and present Key Performance Indicators (KPIs).

  • American Society for Quality (ASQ) certifications a plus.



About Abbott

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 , on LinkedIn at , on Facebook at and on Twitter @AbbottNews and @AbbottGlobal.


please reference job description

Recommended skills

Engineering
Documentation
Change Control
Auditing
Project Management
Software Quality Assurance (Sqa)

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What is the Careerbuilder Estimated Salary?

Only about 20% of the jobs in our search results contain salary information. When a job posting doesn’t include a salary, we estimate it by looking at similar jobs in the same industry in that location. It is not necessarily endorsed by the employer and actual compensation may vary based on your experience.
This estimation is based on Job title, Industry, Location and Skills
$112,080
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Software Quality Engineer
$112,080.00 (Careerbuilder est.)
Estimated Salary: $100K
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