Quality Manager

Abbott Laboratories; Atlanta (GA); On-site; USD 113,000 - 227,000; Full time

Benefits offered by this job

Free medical coverage

Strong retirement plan

Tuition reimbursement

FreeU education benefit

Diversity & inclusion programs

Job summary

Abbott Laboratories in Atlanta, GA, is seeking a Quality Manager within the Heart Failure organization to maintain Quality Management System compliance, oversee CAPA, audits, and external regulatory requirements.

The role leads cross‑functional audit readiness, drives improvements, partners with regulatory bodies, and supports FDA inspections, with a focus on sustainable, compliant quality processes across the site.

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 similarly regulated environments.
• Knowledge of regulations and standards including MDD, MDSAP, MDR, NMPA, CFR 803, 806, and 820, and ISO 13485 and 14971.
• Five (5) years in management capacity.

Responsibilities

• Define and develop 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.
• Act 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.
• Ensure cross-functional partners and peers understand quality system requirements and how they impact product quality and regulatory compliance.
• Represent the site within Abbott through Corporate based community of practice as well as external Regulatory Intelligence Forums.
• Utilize experience and knowledge 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.

Skills

Quality Systems

Regulatory Compliance

Audits

CAPA

Leadership

Quality Assurance

Education

Bachelor’s degree in related field

Job description

Location United States - Georgia - Atlanta Category Quality

Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 122,000 colleagues serve people in more than 160 countries.

Working at Abbott

At Abbott, you can do work that matters, grow, and learn, care for yourself and your family, be your true self, and live a full life. You’ll also have access to:

• Career development with an international company where you can grow the career you dream of.
• Employees can qualify for free medical coverage in our Health Investment Plan (HIP) PPO medical plan in the next calendar year.
• An excellent retirement savings plan with a high employer contribution.
• Tuition reimbursement, the Freedom 2 Save student debt program, and FreeU education benefit - an affordable and convenient path to getting a bachelor’s degree.
• A company recognized as a great place to work in dozens of countries worldwide and named one of the most admired companies in the world by Fortune.
• A company that is recognized as one of the best big companies to work for as well as the best place to work for diversity, working mothers, female executives, and scientists.

The Opportunity

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 andimplement 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
• 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.

Follow your career aspirations to Abbott for diverse opportunities with a company that can help you build your future and live your best life. Abbott is an Equal Opportunity Employer, committed to employee diversity.

Connect with us at www.abbott.com, on Facebook at www.facebook.com/Abbott, and on Twitter @AbbottNews.

The base pay for this position is $113,300.00 – $226,700.00. In specific locations, the pay range may vary from the range posted.

Location United States - Florida - Lake Mary Category Quality

Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and

Job Id 31163430 LocationUnited States - Georgia - Atlanta Medical surveillance No Division HF Heart Failure Travel Yes, 10 % of the Time Additional Location 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)

INNOVATIVE BENEFITS

We support our colleagues around the world as they care for themselves and their families with offerings tailored to their unique needs.

DIVERSITY & INCLUSION

We strive to provide environments where all employees feel welcome and able to bring their full selves to work. To do this we integrate diversity, equity, and inclusion across Abbott.

SUSTAINABILITY FOR OUR FUTURE

At Abbott, sustainability means managing our efforts so we can help the greatest number of people around the world live fuller lives through better health.

WE'RE RECOGNIZED AROUND THE WORLD

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BEST CORPORATE CITIZENS

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THE WORLD

FORTUNE'S MOST ADMIRED COMPANIES

An Equal Opportunity EmployerAbbott is an Equal Opportunity Employer. We are committed to providing equal employment opportunities to all employees and applicants without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, genetic information, protected veteran status, or any other characteristic protected by applicable federal, state, or local law. Employment decisions are based on qualifications, merit, and business needs.> EEO (ENGLISH) > EEO (SPANISH) > PAY TRANSPARENCY NONDISCRIMINATION PROVISIONWe provide reasonable workplace accommodations. U.S. residents only: To request accommodation, please call 224-667-0340or email [e-mail] .Abbott is committed to pay equity and transparency. Compensation is determined using objective, job-related, and gender-neutral criteria in compliance with applicable laws and local regulations.