Program Manager, Quality, Remediation
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Job Location:
Chicago, IL - USA
Yearly Salary:
$ 142400 - 213600
Posted on:
Yesterday
Vacancies:
1 Vacancy
Job Summary
Job Description Summary
The Program Manager Quality Remediation role within Solutions for Enterprise Imaging (SEI) will be responsible for leading the assessment of newly acquired businesses and ensuring alignment of procedures to assure product safety quality and site compliance by driving business alignment to industry requirements including remediation as required.GE HealthCare is a leading global medical technology and digital solutions innovator. Our mission is to improve lives in the moments that matter. Unlock your ambition turn ideas into world-changing realities and join an organization where every voice makes a difference and every difference builds a healthier world.
Job Description
Roles and Responsibilities
Develop execute and track remediation plans to address potential compliance gaps identified through due diligence audits or regulatory findings
Support remediation of legacy systems to meet compliance expectations
Partner with functions to lead remediation of Design History Files (DHFs) Technical Documentation Risk Management Files and labeling as required
Identifies critical path decisions makes recommendations and influences / gets buy-in from segment leadership and business process owners to maximize QMS integration compliance and effectiveness.
Provide clear communication of remediation status risks and timelines to leadership.
Owns all project risk; including time and scope and the associated plans to contain and/or mitigate risk.
Coordinates Operational Reviews working across the organization to ensure targeted outcomes are achieved.
Supports external and internal audit activity as needed.
Required Qualifications
Minimum of Bachelors Degree in Engineering Computer Science or equivalent.
6 years working experience in the medical device industry and/or regulated industry.
Demonstrated understanding or aptitude in Medical Device QMS requirements and regulatory requirements including but not limited to FDA CFR 21 820 and ISO 13485.
Desired Characteristics
Masters Degree in Science or Business Administration.
Experience working with Software as a Medical Device (SaMD).
Experience in integration of acquired businesses including remediation
Experience working and communicating directly with external medical device regulators.
Experience in developing implementing and maintaining quality system processes and driving improvements to processes.
Strong oral and written communication skills. Strong interpersonal and leadership skills. Demonstrated ability to analyze and resolve problems.
Demonstrated ability to lead programs / projects. Ability to document plan market and execute programs. Established project management skills.
We expect all employees to live and breathe our behaviors: to act with humility and build trust; lead with transparency; deliver with focus and drive ownership always with unyielding integrity.
Our total rewards are designed to unlock your ambition by giving you the boost and flexibility you need to turn your ideas into world-changing realities. Our salary and benefits are everything youd expect from an organization with global strength and scale and youll be surrounded by career opportunities in a culture that fosters care collaboration and support.
We will not sponsor individuals for employment visas now or in the future for this job opening. For U.S. based positions only the pay range for this position is $142400.00-$213600.00 Annual. It is not typical for an individual to be hired at or near the top of the pay range and compensation decisions are dependent on the facts and circumstances of each case. The specific compensation offered to a candidate may be influenced by a variety of factors including skills qualifications experience and addition this position may also be eligible to earn performance based incentive compensation which may include cash bonus(es) and/or long term incentives (LTI). GE HealthCare offers a competitive benefits package including not but limited to medical dental vision paid time off a 401(k) plan with employee and company contribution opportunities life disability and accident insurance and tuition reimbursement.Additional Information
GE HealthCare offers a great work environment professional development challenging careers and competitive compensation. GE HealthCare is anEqual Opportunity Employer. Employment decisions are made without regard to race color religion national or ethnic origin sex sexual orientation gender identity or expression age disability protected veteran status or other characteristics protected by law.
GE HealthCare will only employ those who are legally authorized to work in the United States for this opening. Any offer of employment is conditioned upon the successful completion of a drug screen (as applicable).
While GE HealthCare does not currently require U.S. employees to be vaccinated against COVID-19 some GE HealthCare customers have vaccination mandates that may apply to certain GE HealthCare employees.
Relocation Assistance Provided: No
Required Experience:
Manager
Key Skills
- Project Management Methodology
- Project / Program Management
- Program Management
- Management Experience
- Microsoft Powerpoint
- Project Management
- Microsoft Project
- Budgeting
- DoD Experience
- Leadership Experience
- Supervising Experience
- Contracts
About Company
GE HealthCare provides digital infrastructure, data analytics & decision support tools helps in diagnosis, treatment and monitoring of patients
