Program Manager, Global Quality

JOB 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. Youll also have access to:

• Career development with an international company where you can grow the career you dream of.
• Employees can qualify forfree medical coverage in ourHealth Investment Plan (HIP) PPOmedical plan in the next calendar year.
• An excellent retirement savings plan with a high employer contribution.
• Tuition reimbursement theFreedom 2 Savestudent debt program andFreeUeducation benefit - an affordable and convenient path to getting a bachelors 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 AbbottsHeart Failure (HF)division were 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 aProgram Manager- Global Qualityto join ourHeart Failure (HF) Quality Assurance Teamworking out of our locations inPleasanton CA Burlington MAAtlanta GA or Orlando FL. This is a high growth business division working onMechanical Circulatory SupportandPulmonary Pressure Measurement Systems. You will be responsible for leading cross-functional teams and managing projectsfor 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 Abbotts Heart Failure 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 Youll 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

• Bachelors 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:

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.

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The base pay for this position is

In specific locations the pay range may vary from the range posted.

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Manager