Abbott

Manager, Quality Assurance

Abbott • $99K — $198K *
Atlanta, GA 30349In-Person
Healthcare
8 - 10 years of experience
Reposted Today
Be an Early Applicant
Job Overview by Ladders

Qualifications

  • Bachelor's degree in a related field
  • 8 years of experience in Quality Systems, Quality Assurance, or Regulatory Compliance in medical device manufacturing
  • Knowledge of MDD, MDSAP, MDR, NMPA, U.S. CFR 803, 806, and 820, ISO 13485 and 14971 regulations
  • 5 years in a management role

Responsibilities

  • Lead efforts to maintain Quality Management System compliance for Abbott Heart Failure Atlanta
  • Oversee the CAPA System and External Requirements Management System
  • Drive improvements in the CAPA program and strategy for effective investigations
  • Manage change impact assessments for external requirements and ensure timely implementation
  • Serve as the main point of contact for external regulatory bodies and lead audit strategies
  • Foster cross-functional collaboration to implement effective audit readiness programs
  • Analyze audit results and ensure corrective actions are executed effectively

Benefits

  • Health and wellness benefits for employees and their families
  • Diverse career opportunities within the company
  • Support for professional development and continuous learning
  • Encouragement for a safe and professional work environment
Full Job Description
JOB DESCRIPTION:

As a Senior Quality Manager, the individual will play a crucial role within Abbott's Heart Failure organization with primary focus to maintain overall Quality Management System compliance to internal policies, applicable standards and external regulatory requirements.

What You'll Work On

  • The incumbent defines and develops strategy for external and internal audits (Regulatory Agencies, Corporate, Notified Bodies, Certifications etc) to ensure that the site is compliant and audit ready at all times.
  • Acts as a key influential leader, responsible for driving cross-functional audit support and audit readiness initiatives to improve quality systems, and overall organizational compliance to internal/external requirements.
  • Ensures cross-functional partners and peers understand quality system requirements and how they impact product quality and regulatory compliance.
  • Represents the site within Abbott through Corporate based community of practice as well as external Regulatory Intelligence Forums.
  • Utilizes experience and knowledge gained from audits, internal assessments, and cross-business community of practice to proactively address potential compliance gaps.
  • Responsible for oversight and administration of site's CAPA system and driving effective resolutions to identified issues.
  • Responsible for tracking timeliness of change assessments for external requirements and associated metrics.
  • Lead overall compliance lifecycle or similar programs within the site, collaborates with cross functional leadership, establishes effectiveness criteria, and advises Executive Management on the overall compliance status and audit readiness.


Responsibilities
  • Provide leadership to maintain Quality Management System compliance for Abbott Heart Failure Atlanta.
  • Oversee site's compliance lifecycle, CAPA System and External Requirements Management System.
  • Lead site's CAPA program and drive continuous improvements by providing strategic direction for robust CAPA investigations and implementation of global resolutions while ensuring sustainability and effectivity.
  • Manage External Requirements change impact assessment metrics and ensure changes to regulations, standards, Abbott policies etc are implemented timely.
  • Serve as the primary interface with external regulatory bodies, manage internal and external inspections and overall audit strategies including any required responses concerning the site.
  • Provide influential partnership to peers and strategic leadership to other functions within the site to define and implement an effective audit readiness program.
  • Drive key readiness initiatives utilizing risk-based prioritization and mitigation to maintain an audit ready status.
  • Evaluate and monitor the results of external and internal audits. Report the audit results to management and status/execution of corrective actions associated with the audit results.
  • Analyze trends from various sources and proactively address regulatory, compliance, and quality issues.
  • Actively participate in FDA inspections and lead internal/corporate audits, notified body audits and applicable external certification audits including any post-audit responses.
  • Provide support for assessment of published regulatory guidance, changes to standards and Abbott policies to determine their impact and implement risk mitigation strategies at site or site level as applicable.
  • Maintain an understanding of the business climate and relationships while implementing compliance improvement initiatives. Maintain quality excellence in all activities
  • Maintain data analysis requirements for applicable Quality System metrics and Quality Management Reviews (QMRs).
  • Lead, guide and retain a diverse, highly qualified staff and provide ongoing performance feedback. Set goals which align to business plans and manage the execution of goals through coaching and mentoring. Maintains a safe, enthusiastic, and professional work environment.
  • Comply with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments.

Required Qualifications
  • Bachelor's degree in related field
  • Eight (8) years of Quality Systems, Quality Assurance and/or Regulatory Compliance/Affairs experience in medical device manufacturing or other similarly regulated environment.
  • Required knowledge of regulations and standards including MDD, MDSAP, MDR, NMPA, applicable U.S. Code of Federal Regulations (CFR 803, 806, and 820), and ISO 13485 and 14971.
  • Five (5) years in management capacity.

Preferred Qualifications
  • Prior experience in interfacing with Regulatory and Notified Bodies
  • Hands-on experience with CAPAs
  • Experience with Supplier Quality
  • Understands applicability of Quality System Regulations
  • Excellent communication, leadership, and analytical skills
  • Detail-oriented with a strong focus on regulatory compliance.
  • Ability to work independently and as part of a team.
  • Strong problem-solving and decision-making abilities.
  • Proactive and able to manage multiple projects simultaneously.


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

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:
HF Heart Failure

LOCATION:
United States > Atlanta : 387 Technology Circle NW Suite 500

ADDITIONAL LOCATIONS:

WORK SHIFT:
Standard

TRAVEL:
Yes, 10 % 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), 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

Similar Jobs

Ad banner background

Get Ready For Your
Next Interview

More Jobs at Abbott

More Healthcare Jobs

Find similar Manager, Quality Assurance jobs:

NationwideAtlanta, GA