Program Manager, Global Quality

Abbott • Burlington, MA, US

9 days ago

Job type

Full-time

Job description

Program Manager Pleasanton, CA, Burlington, MA, or Atlanta, GA

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 student debt program, and 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.

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 or Atlanta, GA. 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

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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Program Manager Global • Burlington, MA, US