Program Manager, Global Quality at Abbott Pediatrics

Burlington, Massachusetts, United States -

Full Time

Start Date

Immediate

Expiry Date

16 Feb, 26

Salary

254700.0

Posted On

18 Nov, 25

Experience

10 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Quality Improvement, Project Management, Software Development, Regulatory Compliance, Cross-Functional Collaboration, Communication Skills, Risk Management, Process Improvement, Team Leadership, Embedded Software, SaMD, Mobile Applications, Cloud-Based Applications, FDA Guidance, Matrixed Environment, Stakeholder Engagement

Industry

Hospitals and Health Care

Description

Working at Abbott At Abbott, you can do work that matters, grow, and learn, care for yourself and your family, be your true self, and live a full life. You’ll also have access to: Career development with an international company where you can grow the career you dream of. Employees can qualify for free medical coverage in our Health Investment Plan (HIP) PPO medical plan in the next calendar year. An excellent retirement savings plan with a high employer contribution. Tuition reimbursement, the Freedom 2 Save student debt program, and FreeU education benefit - an affordable and convenient path to getting a bachelor’s degree. A company recognized as a great place to work in dozens of countries worldwide and named one of the most admired companies in the world by Fortune. A company that is recognized as one of the best big companies to work for as well as the best place to work for diversity, working mothers, female executives, and scientists. The Opportunity Leading an active lifestyle is important to the many people we serve. In Abbott’s Heart Failure (HF) division, we’re advancing the treatment of heart and vascular disease through breakthrough medical technologies in heart failure, allowing people to restore their health and get on with their lives. We are recruiting for a Program Manager- Global Quality to join our Heart Failure (HF) Quality Assurance Team working out of our locations in Pleasanton, CA, Burlington, MA, Atlanta, GA, or Orlando, FL. This is a high growth business division working on Mechanical Circulatory Support and Pulmonary Pressure Measurement Systems. You will be responsible for leading cross-functional teams and managing projects for harmonizing and improving the design and development quality system with focus on software. Software includes embedded software, SaMD, mobile applications, and cloud-based web applications. The output will support future product development and efficient software maintenance processes for Abbott's Heart Failure business. This high-profile role will focus on software quality system improvements (including tools) from project initiation to implementation which will support the HF strategic plan. The Program Manager will serve as the face of the program within the organization, which includes establishing plans/objectives, reporting core team progress, risks/mitigations, key challenges and proposed resolutions to leadership. What You’ll Work On : Lead cross-functional teams to meet program objectives including scope, budget, and schedule. Core responsibilities include. Prepare and/or support detailed Quality Improvement Plans and other business plans. Establish and prioritize project deliverables. Author and review quality system procedures and work instructions. Lead cross-functional teams to develop project timelines consistent with business strategy and expectations Support audits and present completed and planned development process improvements, as appropriate. Identify and support implementation of harmonized software development tools. Drive program execution per milestone commitments (project timeline) Ensure appropriate impacts, risks, mitigations are developed and communicated in the face of requested or required program commitment changes Prioritize program workstreams, consistent with business strategy Facilitate strong collaboration among cross-functional core team members Communicate with all levels of the organization the objectives, status, risks, and needs for the program Identify potential roadblocks early and lead the team to develop and implement counter measures Interface with appropriate internal and external resources (regulatory agencies, customers, etc.) to ensure development programs meet regulatory and customer requirements Comply with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, company policies, operating procedures, processes, and task assignments Maintain positive and cooperative communications with all levels of employees, customers, contractors, and vendors Required Qualifications Bachelor’s degree in engineering 10+ years of experience in Quality, Engineering and/or R&D within a medical device/biomedical, high technology, and/or any other regulated industry Experience in software product development and process improvement Experience in applying FDA guidance for multiple function devices (regulated and not regulated as a medical device) and creating quality system(s) and associated infrastructure to support. Experience collaborating with project stakeholders (client and internal), end-users, business partners, and technical team members for development of quality systems Strong verbal and written communication skills with ability to effectively communicate with multiple levels in the organization Previous experience working in a matrixed and geographically diverse business environment Preferred Qualifications Advanced level degree(s) in Engineering, Sciences, or a related discipline Software project management experience Program/Project Management certifications Knowledge of FDA Guidance for Artificial Intelligence use in medical devices Learn more about our health and wellness benefits, which provide the security to help you and your family live full lives: www.abbottbenefits.com Follow your career aspirations to Abbott for diverse opportunities with a company that can help you build your future and live your best life. Abbott is an Equal Opportunity Employer, committed to employee diversity. Connect with us at www.abbott.com, on Facebook at www.facebook.com/Abbott, and on Twitter @AbbottNews. The base pay for this position is $127,300.00 – $254,700.00. In specific locations, the pay range may vary from the range posted.

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Responsibilities

Lead cross-functional teams to meet program objectives including scope, budget, and schedule. Author and review quality system procedures and work instructions while ensuring compliance with regulatory requirements.