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 Principal Software Quality Engineer is within our ARDx Informatics business located in Charlottesville Virginia. This role will be responsible for global quality engineering activities through participation and quality oversight of product development, commercialization and sustaining activities consistent with Design Control and SDLC . The primary scope is software quality assurance with the aptitude to apply knowledge and skill to additional quality functional areas such as Supplier Controls, CAPA and Complaint, Non Product Software Validation and Product and Process Controls. The PQE will make independent decisions within broad parameters while assuring that these decisions are compliant with site level policies and procedures and are 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)
- Leads global quality engineering activities in software product development, manufacturing, and support. Participate in engineering design review, verification/ validation activities.
- Defines design document requirements for process and test method validation within Design Control and Software Development Life Cycle (SDLC). Participate in engineering design review, verification/ validation activities. 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. Provides technical expertise in root cause analysis and statistical techniques to identify solutions to a range of problems. Performs CAPA (Corrective Action Preventive Action) and FCA (Field Corrective Action).
- Leads in the creation and improvement of software development, software processes, and documentation processes.
- Leads supplier qualification and maintenance activities. Performs SCAR (Supplier Corrective Action), and process deviation activities.
- Perform/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.
- Leads Risk Management activities. Defines the business results expected from risk management strategies and projects. Assesses internal and external risks associated with specific actions, quantifies risks, seeks input from others, and takes actions to limit the exposure of the division.
- Subject matter expert for the non-product software lifecycle. Reviews and assesses software activities (suppler evaluations, validation, lifecycle deliverable documents) to ensure compliance with applicable procedures, standards and regulatory requirements.
- Supports non-product software validation by assessing the need for validation and preparing and/or supporting protocols, reports and other documentation as required.
- Directs multi-site and business wide software lifecycle activities to accomplish quality system objectives. May direct efforts of others expected to provide design review oversight and guidance.
- Develops local strategy in alignment with the business goals and implements related tactical activities. Translates strategic needs into executable plans.
- 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 BS degree in a scientific or technical discipline preferred or 10+ years of experience in a related field.
- 5 plus years in a regulated environment, preferably in medical devices with excellent understating and knowledge of quality system processes.
- Experience in applying quality regulations and standards (e.g. 21CFR 820, ISO 13485, ISO 14971, IEC62304, IVDD, and working knowledge of current and applicable GMP regulations is required
- Strong analytical skills, ability to organize work in a logical and thorough manner.
- Able of analyzing data to support the development of strategies to effectively manage, enhance, mitigate, and/or resolve potential issues.
- Demonstrate problem-solving skills. Identify and resolve problems in a timely manner. Work collaboratively in group problem solving situations.
- Extrapolate meaningful and defensible conclusions from limited data using analytical methodologies, integrate complex data and identifies critical process variables.
- Highlights issues in a timely manner and presents possible resolutions. Seeks additional information when problem is beyond area of personal expertise.
- Demonstrates project management skills
- Flexibility to adapt to changing assignments and ability to effectively prioritize.
- 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.
- Works in a collaborative, fast-paced, goal-driven environment.
- Possesses interpersonal skills to negotiate and reconcile differences. Removes barriers that block goal attainment
- Able to work independently and report efforts. Takes personal responsibility to resolve issues.
- Demonstrates accountability for complying with local and global Quality System requirements.
- Helps drive and promote understanding of the need for change through the organization.
- Influence outcomes appropriately, influences others to support a course of action, influences activities without reliance on formal authority
- Provide mentoring in quality, compliance, and technical areas across multiple work groups. Provides constructive and timely feedback to ensure compliance and mitigate risk.
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
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.
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