1+ months
2018-03-152018-05-04

Director Quality Compliance

Abbott
Princeton, NJ

At Abbott, we're committed to helping people live their best possible life through the power of health. For more than 125 years, we've brought new products and technologies to the world -- in nutrition, diagnostics, medical devices and branded generic pharmaceuticals -- that create more possibilities for more people at all stages of life. Today, 99,000 of us are working to help people live not just longer, but better, in the more than 150 countries we serve.

Abbott Point of Care is a global leader in providing with-patient diagnostic testing solutions that are fast, portable, accurate and affordable. We are a division of Abbott, a global, diversified healthcare innovator with a legacy of pioneering work in medical diagnostics.

Our i-STAT System is an advanced, handheld system that allows medical staff to perform diagnostic testing without having to leave the patient's side. The system provides real-time, lab-quality results using only a few drops of blood and delivers accurate results in minutes rather than hours. The i-STAT System family of products and services fosters a collaborative, patient-centered environment while driving improved operational performance. Our products can play a valuable role in accelerating the patient-care decision-making process throughout the continuum of care. More than 80,000 i-STAT handhelds are used worldwide by healthcare professionals in a variety of settings.

By choosing to transform the healthcare industry and how we do business, we will continue to provide healthcare professionals with the resources they need to deliver high-quality, efficient and affordable care to the patients they serve.

The Director Quality Compliance leads the Abbott Point of Care quality systems/compliance function worldwide. Directs QA management levels. Has responsibility for managing multiple related departments. Establishes policies appropriate for the function. Interprets and recommends modifications to company and division wide policies and practices. Objectives are defined in collaboration with senior management and results assessed from a long range perspective.

Main responsibilities:

Champions the quality systems and compliance unit

Develops quality system strategies to ensure compliance with global regulatory requirements.

Interacts with senior management and external agencies/regulators concerning matters of significance to the company.

Conducts business and technical briefings for senior management and for external representatives.

Responsible for leading multiple quality system elements.

Implements the quality plan in accordance with the quality objectives and goals.

Determines staffing and other resource requirements needed to achieve business goals and compliance requirements.

Directs complex global cross-functional process improvements.

Responsible for ensuring functional areas of responsibility have adequate training programs for adhering to all safety requirements and business EHS goals.

Develops quality goals based on the business strategies and aligns with other functions in the organization as well as alignment with Corporation.

Establishes and implements necessary communication strategies for the improvement and awareness of quality improvements.

Responsible for department financials and developing cost improvement ideas and strategies.

Education and experience requirements:

4 year degree in a scientific or technical discipline is required. 10+ years of experience in function or related field. Masters & above degree preferred. 6 years of direct management experience.   Must have demonstrated extensive knowledge and experience in a device related discipline and/or business. Cross discipline exposure and knowledge is a plus. Leadership experience is required for management role. Considered a Subject Matter Expert and key contributor to initiatives. Leader and key contributor to initiatives and advancement of the Quality organization. Recognized Leader. Demonstrates strong leadership competencies. Makes decisions and charts course through careful evaluation of risks and benefits with limited information. Builds/drives relationships and teamwork within team and across multiple functions with professional demeanor.
Job Family: Operations Quality
Division: APOC Point of Care
Travel: Yes, 10 % of the Time
Medical Surveillance: No
Significant Work Activities: Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)

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Director Quality Compliance

Abbott
Princeton, NJ

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Abbott
Princeton, NJ
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