QA Director-Operations
GE Healthcare - Princeton, NJ

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GE is an equal opportunity employer, offering a great work environment, challenging career opportunities, professional training and competitive compensation.

The Quality Assurance Director - Operations, as an active member of the management team, is responsible for creating and supporting a Quality culture across sites by driving compliance activities across MDx. This position is responsible for coordinating and streamlining data collection across MDx. He/she will be responsible for developing inputs from the data sources well defined and for improving the efficiencies of this process to allow increased access and time to analyze the business data.

Essential Responsibilities

Monitors, reviews, and recommends approval to Head of Quality for the following areas:

  • Quality projects
  • Purchase Services
  • Travel & Living
  • Non-regulatory training (internal and external)
Creates, maintains, and reports metrics for

  • Quality projects
  • Purchase Services
  • Travel & Living
  • Non-regulatory training (internal and external)
  • Identified additional metrics monitoring and improvement opportunities
Organizes, leads, and administrates cross-functional meeting such as

  • Staff meetings
  • Operational meetings
  • Strategic meeting
Provides logistical support during regulatory inspections and external audits

Manages, project manages or monitors special projects as needed

Serving on the Quality Assurance Leadership Team (QALT)


Bachelor’s degree

Minimum 8 years Quality Assurance/Regulatory Assurance experience

Minimum 5 years experience in the medical device or pharmaceutical industry

Minimum 4 years supervisory/management experience

Demonstrated knowledge of Quality Systems (demonstrated experience with ISO, GxP, FDA and other key regulatory bodies) and experience with new product introduction process (NPI)

Knowledge of and exposure to manufacturing or engineering processes

Ability to communicate using English (or local language)

Extensive prior experience using word processing, spreadsheet, and presentation software

Must be willing to travel at least 20% of the time (based on the need of the position)

Additional Eligibility Qualifications

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 background investigation and drug screen.

Desired Characteristics

1. Demonstrated leadership experience such as work planning, delegating and evaluating

2. Global regulatory experience & demonstrated experience interfacing with FDA

3. Familiar with classic Quality tools & experienced in applying them to monitor function performance

4. Demonstrated project management skills to plan & deliver on established strategic goals

5. Ability to successfully identify, assess & manage risk proactively & be accountable for actions/tough decisions

6. Visibly demonstrates comfort & efficacy in presenting to and in communicating with others including regulatory agencies & business leaders

7. Strong business acumen-understands key financial metrics, understands business trends & cycles & is able to influence key business strategies & initiatives, demonstrates knowledge of key business measurements (i.e., market, suppliers, competition, performance measures) & is able to link QA strategy to this framework

8. Strong influencing & relationship building, mentoring, coaching & networking skills

9. Business partnership skills: can interface with top organizational leadership & internal & external customers, responding in a professional manner

10. Demonstrated collaboration, negotiation & conflict resolution skills

11. Ability to effectively lead, acknowledge, develop, communicate & implement a strategy under crisis situations to ensure compliance

12. Strong technical aptitude (i.e. able to read & comprehend technical documentation & execute procedures)

13. Integrity: Adhering to high ethical, moral & personal values in decisions, communications & actions

14. Inclusiveness: Building a connection with the team through personal involvement & trust & providing feedback & coaching to help develop others

15. Clear thinker: Simplifying strategy into specific actions with clear accountability, making decisions with speed & accuracy based on best available information & communicating priorities clearly . Excellent organization skills.

16. Expertise: Has confidence & perspective the comes through depth in industry to impact growth, demonstrating leadership throughout different business cycles & continually striving to increase knowledge

17. Imagination: Taking risks on people & ideas, generating new & unique ideas & acting as an advocate of innovation to accelerate GEHC competitive advantage

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