Quality Manager

Thornton Tomasetti; Atlanta (GA); On-site; USD 113,000 - 227,000; Full time

Benefits offered by this job

Free medical coverage (HIP PPO)

High employer retirement contribution

Tuition reimbursement

FreeU education benefit

Diversity and inclusion recognition

Job summary

Abbott Heart Failure Atlanta seeks a Quality Manager to maintain the Quality Management System, ensuring regulatory compliance and audit readiness across the site.

The role leads CAPA, manages external requirements, and partners with cross-functional teams to implement risk-based improvements, including FDA readiness and inspections.

Qualifications

• Bachelor’s degree required in a related field.
• 8+ years in Quality Systems, QA, or Regulatory Compliance in regulated environments.
• Strong knowledge of CFR, MDR/MDSAP, ISO 13485/14971.
• Experience in managing teams and CAPA processes.

Responsibilities

• Maintain Quality Management System compliance for Abbott Heart Failure Atlanta.
• Oversee External Requirements and CAPA systems and drive improvements.
• Lead CAPA program with effective investigations and global resolutions.
• Manage change impact assessment metrics for regulatory requirements.
• Interface with external regulatory bodies; oversee inspections and audits.
• Provide leadership to define and implement audit readiness programs.

Skills

Quality systems

Regulatory compliance

Audit experience

Leadership

Communication skills

Education

Bachelor’s degree

Tools

CAPA system

Job description

Job Description

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 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
• 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.

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.

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: No

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)

Abbott is an Equal Opportunity Employer of Minorities/Women/Individuals with Disabilities/Protected Veterans.

EEO is the Law link - English: http://webstorage.abbott.com/common/External/EEO_English.pdf

EEO is the Law link - Espanol: http://webstorage.abbott.com/common/External/EEO_Spanish.pdf

Abbott is about the power of health. For more than 135 years, Abbott has been helping people reach their potential — because better health allows people and communities to achieve more.

We invite you to explore opportunities at Abbott, to see if your talents and career aspirations may fit with our openings. An equal opportunity employer, Abbott welcomes and encourages diversity in our workforce.

Follow Us: Facebook LinkedIn YouTube Twitter