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Manager Product Quality Engineer

Company: Abbott Laboratories
Location: Harrisonburg
Posted on: November 25, 2022

Job Description:

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 113,000 colleagues serve people in more than 160 countries.

Manager Product Quality Engineer

Charlottesville, VA

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 107,000 colleagues serve people in more than 160 countries

About Abbott

Diagnostic testing is a compass, providing information that helps in the prevention, diagnosis, and treatment of a range of health conditions.

Abbott's life-changing tests and diagnostic tools give you accurate, timely information to better manage your health. We're empowering smarter medical and economic decision-making to help transform the way people manage their health at all stages of life. Every day, more than 10 million tests are run on Abbott's diagnostics instruments, providing lab results for millions of people.

Our location in Charlottesville, VA currently has an opportunity for a Manager Product Quality Engineer within our Cardiometabolic & Informatics business unit. This role will be responsible for overseeing and managing the complaint escalation process, CAPA, root cause analysis, metrics, CAPA Review Board, and support resolution of on-market product quality issues. globally across the Informatics business Provide direct management and counsel to Product Support staff to assure that process is followed, and goals are met. Participate in strategy development and translate strategy into specific actions. Assure projects are completed within time and compliantly. Establish department goals and plans to meet them.


The position 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 when providing product and technology support solutions to customers. Works as an individual contributor and manages others during routine and crises. Provides a quick, detailed assessment of the problem, outlining the scope and magnitude of the issues. Coordinates Quality, Engineering and Operations teams as needed, presents long and short-term options, solves problems with minimal disruption to operations and develops policies to minimize recurrence and provide guidance and oversees work of other Product Support Specialists and Quality team members Level of accountability spans the business and CM&I BU

  • Manage and develop the Product Support team (or Product Quality team) to ensure they have the proper training, tools, and competence to implement and maintain the effectiveness of the quality system.
  • Formulates long-term strategic objectives, develops and implements the quality plan in accordance with the quality objectives/goals, and maintains the effectiveness of the quality system.
  • Develops quality goals based on the business strategies, collaborates with other business units on common goals, and drives for results. Achieves goals through interaction with individuals not under direct supervision.
  • Responsible for leading the complaint escalation process, including documentation, coordination of investigation, determination of risk, root cause and corrective and preventative actions.
  • Provides technical/ quality expertise and leadership to direct reports and others. Level load resources across a major product issues and cases across of the business
  • The liaison between Operations/Support and Software Development teams to facilitate and coordinate resolution activities for on-market product quality issues.
  • Able to assess a customer complaint for Medical Device Reporting requirements. Identify and escalate cases with potential regulatory actions. Advise management of significant product issues and unresolved customer issues.
  • Manages the decision-making process among Product Support team and creates a work environment that supports team effectiveness.
  • Identifies metrics to consistently measure and demonstrate timely completion of Nonconformance and CAPA activities. Creates appropriate messaging; dashboards to facilitate communication to all levels of the organization.
  • Keeps senior management informed of quality issues affected by other business plans and strategies. Direct quality operations via direct staff. Provide strategic and tactical direction for area of responsibility.
  • Lead a team through investigations, risk assessments and corrective actions of CAPAs.
  • Lead Quality System improvement projects following DMAIC/DMADV methodologies and project management.
  • Lead Quality requirements within the design transfer, design control and improvement project teams.
  • Identifies and secures business staffing and resources, delegates responsibility and authority to team members on the basis of work
  • Consults to ensure that product safety and efficacy have been evaluated and issues related to safety/patient results are elevated for risk evaluation.
  • Ensures complaints and nonconformances meet the requirements listed within the operating procedures.
  • Evaluates complaints and nonconformances for product impact, completion of corrections, need for further investigation; and need for global action. Recommend revisions where deficiencies are found.
  • Provides assistance to customers including problem solving, and technical information regarding the use of software applications.
  • Provides the highest level of escalated support concerning all Informatics products.
  • Determines urgency level and communicates accurately with key stakeholders.
  • Keeps informed and promotes awareness of all product changes.
  • Highlights issues and presents possible resolutions. Seeks additional information when problem is beyond area of personal expertise
  • Develop Product Support team's objectives, leads team decisions and works toward their implementation displaying sensitivity to group dynamics
  • Generates metrics with assistance to communicate and track product quality issues.D
  • 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.

    • BS degree in in Science or Engineering or technical discipline, advanced degree (MS/PhD) preferred
    • Minimum 8 yrs of related work experience
    • 10 years of experience in a regulated environment, with excellent understating and knowledge of quality system processes.
    • Previous quality engineering and product support experience and demonstrated use of quality tools/methodologies
    • Knowledge of regulations and standards affecting software development and overall design control for medical devices.
    • 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
    • Understanding and experience with Software Development Lifecycle Management,
    • Agile methodology preferred.
    • Experience with Salesforce, TCP/IP, VPN Connectivity, Networks, IIS, HL7 interfaces, email client programs and protocols, VMWare, Crystal Reports, SQL Server, Medical terminology, HTML and XML.
    • Working knowledge and experience complaints, CAPA and root cause analysis.D

      • Medical Devices Industry experience
      • Strong problem-solving skills and necessary persistence to work around "roadblocks".
      • Reviews and analyzes data, draws effective conclusions. Understands experimental design. Can apply knowledge to data analysis and problem-solving situation.
      • Strong penchant for asking questions and a natural curiosity to understand the root cause of a technical issue.
      • Ability to work in a fast-paced environment, handling multiple assignments simultaneously while ensuring the customer's issue has been addressed properly.
      • Directly confronts rather than avoids conflicts, depersonalizes conflict situations by focusing on issues rather than personalities and actively searches for win-win solutions.
      • Excellent listening skills with the ability to manage challenging customer interactions.
      • Ability to communicate effectively with customers in a courteous and professional manner.
      • Appropriately influences others to support a course of action. Influences activities without reliance on formal authority. Removes barriers that block goal attainment and drives change through the organization;
      • Ability to prioritize workload to ensure critical issues are handled in a timely manner.
      • Demonstrates accountability for complying with Quality System requirements.
      • Committed to improving quality and performance of all Informatics products . click apply for full job details

Keywords: Abbott Laboratories, Harrisonburg , Manager Product Quality Engineer, Executive , Harrisonburg, Virginia

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