Senior Quality Program Manager 2 - Digital Integrations

Company: General Electric
Location: Waukesha
Posted on: June 4, 2021

Job Description:

Job Description Summary

Develop and maintain systems, rules, and processes to ensure fulfillment of internal and external requirements that support the GEHC Quality Management System including validation compliance activities for non-product computer system validation (CSV). Ensures that projects and products are capable and will meet specified standards (Preventive). Interprets simple internal and external business challenges and recommends best practices to improve products, processes or services. Ensures deployed procedures and processes are operationalized to employees across IT, Manufacturing, Service, Operations, and Quality/Regulatory functions. Stays informed of industry trends that may influence work.

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

• Drives and is accountable for operational excellence of assigned program(s), with duties including project reviews, feasibility analysis, cost benefit analysis, prioritization, resourcing, initiation, execution and closure for all project work related to the program
• Clearly communicates program status, issues, risks, plans, etc. to senior management
• Manages budgets and contracts associated with program(s) or initiative(s) as applicable
• Manages activities of project team resources to support and deliver solutions relating to the program(s) , including the development of internal and external communications, establishing roadmaps and benchmarks, requirements gathering, development, implementation, testing and training plans, and ensuring the successful transition to the functional owners
• Maintains effective working relationships with peers and vendors to seamlessly integrate the program area into the overall strategic objectives and activities of the organization
• Coordinates program and validation support activities, including education and training cross-functional teams to ensure adoption of best practices, continuous improvement processes and standardized work through the Quality System
• Provides on-site implementation, validation, and audit support
• Assist teams in identifying and remediating compliance risks. Support planning and execution of risk retirement actions

Required Qualifications

• Bachelor's degree in engineering or technical discipline plus 4 years working experience within healthcare regulations. Understanding of product development, IT systems, manufacturing, quality control and servicing in a medical device environment.
• Demonstrated program/project management experience in a global environment, including project initiation, scoping, resourcing, scheduling, budgeting, requirements gathering, risk management, and communication
• Demonstrated experience in Quality Systems, Process Validation, and Computer System Validation
• Process improvement experience, knowledge of continuous improvement methodologies & in-depth understanding of related processes

Desired Characteristics

• Masters degree in engineering or other technical discipline
• Demonstrated experience with regulations in the medical device and/or pharmaceutical industries (e.g. FDA CFR 58, 211, 820, 600 and EU GMPs)
• Experience with USP, EP, ICH Standards, PDA/ISPE guidance, and ISO certifications
• Demonstrated knowledge of Quality Management System tools
• LEAN experience
• Demonstrated ability to excel in a global matrix organization

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 you'd expect from an organization with global strength and scale, and you'll be surrounded by career opportunities in a culture that fosters care, collaboration and support.

Additional Information

GE offers a great work environment, professional development, challenging careers, and competitive compensation. GE is an Equal 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 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).

Relocation Assistance Provided: No

Keywords: General Electric, Waukesha , Senior Quality Program Manager 2 - Digital Integrations, Other , Waukesha, Wisconsin