Abbott

Director, Instrument Quality Assurance

Abbott • $171K — $342K *
Irving, TX 75061In-Person
Pharmaceuticals & Biotech
8 - 10 years of experience
Today
Be an Early Applicant
Job Overview by Ladders

Qualifications

  • Bachelor's degree in a related field or equivalent experience.
  • 8+ years in a leadership role related to quality in medical devices or pharmaceuticals.
  • Strong knowledge of Quality System Regulations and international regulatory requirements for medical devices.
  • Proven advanced leadership abilities for building and developing large teams.
  • Excellent verbal and written communication skills.

Responsibilities

  • Lead all aspects of the business unit's Quality System globally.
  • Ensure compliance with corporate and worldwide regulatory standards.
  • Oversee quality for multiple diagnostic platforms such as Immunoassay and Clinical Chemistry.
  • Manage areas of the global Quality System including CAPA and Design QA/Document Control.
  • Align quality policies and programs with division and corporate strategies.
  • Set and achieve both short- and long-term goals for the Quality organization.
  • Act as the Management Representative for the Quality System and interface with regulatory agencies.

Benefits

  • Comprehensive health and wellness benefits for employees and families.
  • Diverse career opportunities within the organization for professional growth.
Full Job Description
JOB DESCRIPTION:

WHAT YOU'LL WORK ON:

Responsible for all aspects of the business unit Quality System worldwide. Leads quality related resources for the entire product life cycle associated with the development, production and distribution of products. As member of the leadership team, develop and implement multi-year business and quality strategies.

  • Responsible for the operations, results, and continuous improvement of the Quality System.
  • Ensures that all systems are operated in accordance with corporate and worldwide regulatory requirements.
  • Provides leadership and quality oversight across multiple diagnostic platforms, including Immunoassay, Clinical Chemistry, and Hematology, ensuring consistent application of quality standards, regulatory compliance, and lifecycle excellence across all technologies.
  • Elements of the global Quality System include Quality Systems & Compliance, Design QA/Document Control, CAPA, Operations QA, and Incoming QA.
  • Works with Division and Corporate to ensure alignment with quality policies and programs.
  • Responsible for establishing and achieving the short- and long-term goals and objectives for the Quality organization.
  • Develops plans to achieve these objectives.
  • Serves as the Management Representative for the Quality System.
  • Interfaces with the FDA and other regulatory agencies for quality and compliance issues.
  • Coaches, develops, and motivates the organization to build a sustainable pipeline of leaders.
  • Acts as a model leader in the organization.
  • Ensures the systems necessary to support the effective application and monitoring of the Quality System are implemented.
  • Responsible for implementing and maintaining the effectiveness of the Quality System, including the resources to support it.
  • Accountable for the operations, results, and continuous improvement of the Quality System.


REQUIRED QUALIFICATIONS:
  • Bachelor's degree in a related field or an equivalent combination of education and work experience.
  • 8+ years of experience in leading an organization in quality and/or medical device/pharmaceutical related discipline.
  • Knowledge and application of the principles of the Quality System Regulations and other international regulatory requirements governing medical device manufacturing and distribution required.
  • Advanced leadership skills. Ability to build and develop a large organization.
  • Excellent verbal and written communication skills.


APPLY NOW:

Learn more about our health and wellness benefits, which provide the security to help you and your family live full lives: www.abbottbenefits.com

Follow your career aspirations to Abbott for diverse opportunities with a company that can help you build your future and live your best life.

The base pay for this position is
$171,300.00 - $342,700.00
In specific locations, the pay range may vary from the range posted.

JOB FAMILY:
Operations Quality

DIVISION:
CRLB Core Lab

LOCATION:
United States > Irving : LC-8

ADDITIONAL LOCATIONS:

WORK SHIFT:
Standard

TRAVEL:
Yes, 10 % of the Time

MEDICAL SURVEILLANCE:
Not Applicable

SIGNIFICANT WORK ACTIVITIES:
Keyboard use (greater or equal to 50% of the workday)

About Abbott

Abbott Careers

Joining Abbott means becoming part of a globally diverse team dedicated to making a lasting impact on human health. As a leader in healthcare innovation, Abbott provides a dynamic workplace where careers flourish through growth, leadership, and diversity training.

Opportunities at Abbott

Explore a world of opportunities with our team. Whether you're seeking job opportunities in engineering, marketing, research, or healthcare, Abbott offers a variety of positions that allow professionals to grow their careers. Our commitment to diversity and innovation is evident in every aspect of our work, fostering an inclusive culture that values each team member's contribution.

Work You'll Do

At Abbott, every role contributes to our mission of helping people live fuller lives through better health. From groundbreaking research in medical devices to advancements in pharmaceuticals, our team is at the forefront of healthcare innovation. By joining Abbott, you are not just accepting a job; you are embarking on a path of professional and personal growth.

Internship Programs

Kickstart your career with an Abbott internship. Our programs provide invaluable industry experience and a chance to develop essential skills in a real-world setting. Interns at Abbott work on projects that matter, gaining the experience and knowledge necessary to succeed in their future careers.

Professional Development

Abbott is dedicated to the continuous professional development of its employees. With access to cutting-edge technology, leadership programs, and diversity training, our team members are equipped to lead and innovate within the healthcare industry. We support your career journey with robust training programs, mentorship, and opportunities for networking and professional growth.

Benefits and Culture

Our employees enjoy comprehensive benefits designed to support their life and well-being. From health insurance to retirement plans, we ensure our team has everything they need to thrive. Abbott's culture is built on a foundation of respect and integrity, united by a shared commitment to improving health outcomes.

Join Our Team

Discover the impact you can make with a career at Abbott. We are hiring individuals who are passionate, curious, and driven to lead. Search open positions that match your skills and interests on our Jobs page. Prepare your resume, sharpen your interview skills, and get ready to join a team that's at the cutting edge of healthcare solutions.

Stay Connected

Keep up to date with career tips, industry insights, and company news—all from the people who work here. Subscribe to our Careers Blog and personalize your subscription to receive job alerts and insider tips tailored to your preferences.

Explore Abbott

With a commitment to improving life through innovation, leadership, and diversity, Abbott is a place where you can fulfill your potential. See what exciting and rewarding opportunities await at Abbott by exploring our career opportunities today.

SEARCH ABBOTT JOBS

Join us in our mission to make the world a healthier place through innovation, leadership, and diversity. Your journey to a fulfilling career at Abbott starts here.
Learn more about Abbott
Size
113,000 employees
Market Cap
$189 billion
Industry
Healthcare
Net Income
$4.4 billion
Founded
1944
5 Year Trend
+15.6%
Revenue
$34.6 billion
NASDAQ
ABT
* Ladders Estimates

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