Director, Quality & Regulatory Business Development-2 at GE HealthCare

**Who this is for** This leadership role is for a senior professional with extensive medical device industry experience, focused on bridging the gap between qua

Work type: unknown

Location: Waukesha

Type: Full-time

Summary

**Who this is for** This leadership role is for a senior professional with extensive medical device industry experience, focused on bridging the gap between quality/regulatory requirements and business growth strategies. **Key highlights** You will own business process management and quality system integration, providing strategic guidance to leadership to ensure that products and services consistently meet global standards and business objectives. **You might be a good fit if you...** - Possess significant experience managing QMS and regulatory requirements (FDA/ISO). - Have a demonstrated history of leading functional teams and complex, high-impact projects. - Are skilled at translating high-level strategy into actionable, standardized processes. - Can influence organizational leadership and drive accountability across diverse teams.

Job Description

# Job Description Summary

Managing, analyzing, integrating and improving business development capabilities. Develop and maintain systems, rules, and processes to ensure fulfillment of internal and external requirements. Ensures that projects and products are capable and will meet specified standards. Interprets internal and external business challenges and recommends best practices to improve products, processes or services. 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

Business Process Management Systems (e.g., Quality Management Systems, Integrated Management Systems). Work to develop, implement, and monitor overall process mapping for quality improvement purposes.

Drive standardization of processes, tools, and performance management systems.
Requires specialized depth and/or breadth of expertise within the discipline. May require strong commercial awareness and is expected to influence strategy development within the functional area, including control of resources and input into policy formulation.
May lead functional teams or projects with minimal resource requirements, risk, and/or complexity.
Communicates difficult concepts and may influence others’ opinions on particular topics. May guide others to consider different points of view.
Impacts the team’s ability to achieve service, quality, and timeliness objectives. Work is subject to functional policy objectives.
Regularly advises management within the function and/or the business. Maintains a supportive role in decision-making on important matters.
High levels of evaluative judgment are required to achieve desired outcomes.
Uses a high level of judgment to make decisions and manage complex tasks or problems that impact the function.
Demonstrates the ability to assess the quality of information provided and ask pertinent questions of stakeholders.
Able to develop novel solutions outside of established parameters and construct well-reasoned recommendations.
Utilizes multiple internal and some external sources outside of the immediate function to inform decision-making.

Required Qualifications

Master’s degree with a minimum of 5 years of experience in the medical device industry; or Bachelor’s degree with a minimum of 10 years of experience in the medical device industry; or High School Diploma with a minimum of 15 years of progressive responsibility in the medical device industry.

Experience with medical device QMS and regulatory requirements, including but not limited to FDA 21 CFR Part 820 and ISO 13485.

Desired Characteristics

Demonstrated ability to lead programs and projects.

Ability to document, plan, market, and execute programs.
Established project management skills.
Demonstrated ability to analyze and resolve problems.
ASQ certification (CQE, CQA, etc.) and/or Lean certification (Green Belt, Black Belt) preferred.
Ability to translate strategy into specific actions with clear accountability; make decisions with speed and accuracy based on the best available information; and communicate priorities clearly and concisely.
Ability to interface with senior organizational leadership and internal and external customers in a professional manner.
Ability to energize others by building strong team connections through personal involvement and trust, providing feedback and coaching, and driving accountability.
Strong oral and written communication skills in English.
Integrity: Accepts and adheres to high ethical, moral, and personal values in decisions, communications, and actions.
Ability to travel domestically and internationally up to 20%.
Minimum of 5 years of experience directly driving global programs to resolve quality compliance issues.

### Note

To comply with U.S. immigration and other legal requirements, it is necessary to specify the minimum number of years of experience required for any role based in the United States. For roles outside the U.S., to ensure compliance with applicable legislation, job descriptions should focus on the substantive level of experience required, and a minimum number of years should not be specified.

We will not sponsor individuals for employment visas, now or in the future, for this job opening.

# Additional Information

GE HealthCare offers a great work environment, professional development, challenging careers, and competitive compensation. GE HealthCare is an [Equal Opportunity Employer](https://www.eeoc.gov/sites/default/files/2022-10/22-088_EEOC_KnowYourRights_10_20.pdf)[.](http://www.ge.com/sites/default/files/15-000845%20EEO%20combined.pdf) 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

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