Abbott

Manager, Quality

Abbott • $99K — $198K *
Plano, TX 75025In-Person
Pharmaceuticals & Biotech
5 - 7 years of experience
Reposted 6 days ago
Job Overview by Ladders

Qualifications

  • Bachelor's degree or equivalent combination of education and experience
  • 5+ years of relevant quality experience
  • Ability to monitor progress towards departmental goals
  • Willingness to work in a quality system environment
  • Capability to develop new work processes and resource utilization
  • Problem-solving ability impacting work processes and personnel

Responsibilities

  • Implement staffing plans by identifying resource needs and coordinating hiring processes
  • Develop direct reports through training and performance reviews
  • Monitor daily operations and provide guidance to staff
  • Serve as process owner for FDA QSR and ISO 13485 compliance
  • Ensure QMS effectiveness and sustainability across operations
  • Lead updates in QMS in response to regulatory and internal changes
  • Represent the QMS during internal and external audits

Benefits

  • Health and wellness benefits to support life balance
  • Diverse career opportunities within the company
  • Supportive culture encouraging professional growth and development
  • Access to resources for continuous improvement initiatives
Full Job Description
JOB DESCRIPTION:

Job Title

Manager, Quality

The Opportunity

This position works on site out of our Plano, TX site supporting the Neuromodulation division. Our Neuromodulation business includes implantable devices compatible with mobile technology to help people who suffer from chronic pain and movement disorders. These non-opioid therapies allow us to provide interventional pain therapy to patients throughout the pain continuum.

The Quality System Manager is responsible for developing, maintaining, and continuously improving the company's Quality Management System (QMS) to ensure compliance with FDA 21 CFR Part 820, ISO 13485, and applicable global regulatory requirements. This role serves as the quality system owner and partners cross-functionally to drive compliance, inspection readiness, and quality culture.

What You'll Work On
  • Implements a staffing plan by identifying resource requirements, writing justifications for additional personnel, obtaining approval for changes, and coordinating the selection process with Human Resources.
  • Develops direct reports by securing appropriate training, assigning progressively challenging tasks, applying progressive disciplinary action as appropriate and conducting formal written and verbal performance reviews.
  • Monitors daily work operations and provides direction and guidance to, experienced exempt employees, or skilled nonexempt staff to achieve unit or project goals.
  • Serve as the process owner for the Quality Management System aligned with FDA QSR, ISO 13485, and company procedures
  • Ensure QMS effectiveness, compliance, and sustainability across all operational areas. Monitors compliance with company policies and procedures (e.g. compliance with FDA, BSI, EEO regulations etc).
  • Lead QMS updates in response to regulatory changes, internal findings, or business growth
  • Lead and represent the QMS at internal and external audits, including FDA, ISO, Notified body. Demonstrates confidence and leadership during audits and inspections, representing the quality system with credibility and clarity.
  • Owns CAPA process and CAPA monitoring.
  • Drive continuous improvement initiatives across the QMS. Identifies, develops and implements processes to improve department performance.
  • Implements improvements to Quality Systems and tools by directing personnel to gather data on existing quality tools, identify weaknesses, and research/select new tools based on findings.
  • Establish, monitor, and trend QMS metrics and key performance indicators (KPIs). Trend quality system metrics and present data to management.
  • Promote a culture of proactive compliance, accountability, and continuous improvement
  • Monitors departmental activities and records to ensure compliance independent action through critical decision making.
  • Ensures sustaining support of Quality System by individually working quality system issues and by delegating project work for maintaining quality system capability.
  • Other responsibilities as needed.
  • Influence/Leadership:
  • Promotes the attainment of group goals by selecting, motivating, and training capable staff
  • Leads through influence, partnering cross-functionally to embed quality system requirements into daily operations.
  • Champions a culture of quality and accountability across the organization.
  • Proactively drives alignment between business objectives and regulatory requirements.


Required Qualifications
  • A Bachelor's degree or an equivalent combination of education and work experience
  • 5+ years of relevant work experience in quality
  • Ability to monitor progress of exempt individuals, teams, supervisors or nonexempt technical individuals toward departmental goals
  • Willingness to perform this job in a quality system environment. Failure to adequately perform tasks can result in noncompliance with governmental regulations
  • Ability to develop and/or identify new work processes and the improved utilization of human and material resources within the assigned area or related departments; facilitates others involvement in the continuous improvement program
  • Ability to investigate and solves problem that impact work processes and personnel within the assigned unit


Preferred Qualifications
  • Solid knowledge of FDA regulations and guidelines and a deep understanding of medical device industry
  • Strong analytical, organizational, and problem-solving skills
  • Previous work experience with external audits and CAPAs.


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
$99,300.00 - $198,700.00
In specific locations, the pay range may vary from the range posted.

JOB FAMILY:
Operations Quality

DIVISION:
NM Neuromodulation

LOCATION:
United States > Texas > Plano : 6901 Preston Road

ADDITIONAL LOCATIONS:

WORK SHIFT:
Standard

TRAVEL:
Yes, 5 % of the Time

MEDICAL SURVEILLANCE:
Not Applicable

SIGNIFICANT WORK ACTIVITIES:
Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day), Continuous standing for prolonged periods (more than 2 consecutive hours in an 8 hour day), Continuous walking for prolonged periods (more than 2 hours at a time in an 8 hour day)

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.

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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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