Abbott

Director, Quality

Abbott • $172K — $344K *
Sylmar, CA 91342In-Person
Healthcare
11 - 15 years of experience
Today
Be an Early Applicant
Job Overview by Ladders

Qualifications

  • Bachelor's degree, preferably in Microbiology.
  • 15 years of experience in engineering, quality, or microbiology, with a focus on medical device regulations.
  • Expertise in hosting regulatory audits specific to medical devices.
  • In-depth knowledge of microbiology and sterilization techniques.
  • Experience in leading quality management system improvements in regulated environments.

Responsibilities

  • Organize and execute regulatory audits across the global CRM network.
  • Oversee microbiology and sterilization efforts, particularly in the Sylmar facility.
  • Develop and implement strategies for Quality Management System evolution and compliance.
  • Manage supplier relationships and modernize Quality Management System tools.
  • Drive continuous improvement initiatives and adapt to evolving global regulations.
  • Lead talent development and budget management within the team.
  • Collaborate with regulatory agencies, including the FDA, to maintain compliance and facilitate product launches.

Benefits

  • Health and wellness benefits to support personal and family needs.
  • Opportunities for career advancement and professional growth.
  • A supportive work environment that encourages innovation and development.
Full Job Description
JOB DESCRIPTION:

THE OPPORTUNITY:

This role with lead CRM global Quality System Management and Audit, as well as CRM global Microbiology & Sterilization oversight, including direct oversight of the Sylmar Microbiology/Sterilization based team and operation for production manufacturing.

WHAT YOU'LL WORK ON:

  • Organizing, hosting, and executing regulatory audits across the global CRM network. Develop and drive audit strategies and plan across CRM global network/sites, in alignment with increasing complexity from global regulatory agencies.
  • CRM network microbiology and sterilization oversight, as well as direct leadership responsibility over Sylmar based micro/sterilization team and production operation. Drive sterilization acceptance approaches / compliance with appropriate standards across the CRM global manufacturing network.
  • Quality Management System (QMS) evolution, upkeep, and compliance. Develop and drive strategies for implementation of Quality tools, demonstrating acceptability within the quality system.
  • QMS supplier management, modernization of QMS tools
  • Continuous improvement, upkeep with evolving global regulations, and modifying QMS (particularly in the advent of AI applications to product offerings and within QMS execution)
  • Talent development and management, organizational development, budget management
  • Direct work with FDA and other geographic regulators to enable continued good standing of the CRM business to enable unincumbered launch cadence of new product iterations into the market


QUALIFICATIONS:

  • Bachelor's degree. Degree in Microbiology highly preferred.
  • 15 years of experience within engineering, quality, microbiology, or related experience. In-depth knowledge and experience required in medical device regulated businesses, specifically in hosting regulatory audits; additionally expertise in microbiology and medical device sterilization techniques.


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
$172,000.00 - $344,000.00
In specific locations, the pay range may vary from the range posted.

JOB FAMILY:
Operations Quality

DIVISION:
CRM Cardiac Rhythm Management

LOCATION:
United States > Sylmar : 15900 Valley View Court

ADDITIONAL LOCATIONS:

WORK SHIFT:
Standard

TRAVEL:
Not specified

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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