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Abbott

Makes heart devices, glucose sensors and lab tests

Quality Manager

Validation, Compliance & Quality SystemsConfirmed live in the last 24 hours
Full-timeAtlanta, GA, USA$113.3k - $226.7k

About the Job

Requirements

  • A bachelor's degree in a related field is required.
  • Eight years of Quality Systems, Quality Assurance, and/or Regulatory Compliance/Affairs experience in medical device manufacturing or a similarly regulated environment are required.
  • Five years of experience in a management capacity are required.
  • Knowledge of MDD, MDSAP, MDR, NMPA, applicable U.S. Code of Federal Regulations (CFR 803, 806, and 820), and ISO 13485 and 14971 is required.
  • Prior experience interfacing with Regulatory and Notified Bodies is preferred.
  • Hands-on experience with Corrective and Preventive Actions (CAPAs) is preferred.
  • Understanding the applicability of Quality System Regulations is preferred.
  • Strong problem-solving and decision-making abilities are preferred.
  • Ability to manage multiple projects simultaneously is preferred.

Responsibilities

  • Define and develop strategies for external and internal audits, including regulatory agency, corporate, notified body, and certification audits, to ensure site compliance and audit readiness.
  • Drive cross-functional audit support and audit-readiness initiatives to improve quality systems and organizational compliance with internal and external requirements.
  • Ensure cross-functional partners and peers understand quality system requirements and their impact on product quality and regulatory compliance.
  • Represent the site in Abbott corporate communities of practice and external Regulatory Intelligence Forums.
  • Use audit, internal assessment, and cross-business community-of-practice experience to proactively address potential compliance gaps.
  • Oversee and administer the site's CAPA system and drive effective resolutions to identified issues.
  • Track the timeliness of change assessments for external requirements and associated metrics.
  • Lead compliance lifecycle or similar programs at the site, collaborate with cross-functional leadership, establish effectiveness criteria, and advise Executive Management on compliance status and audit readiness.
  • Provide leadership to maintain Quality Management System compliance for Abbott Heart Failure Atlanta.
  • Oversee the site's compliance lifecycle, CAPA System, and External Requirements Management System.
  • Lead the site's CAPA program and drive continuous improvement by providing strategic direction for robust CAPA investigations and implementation of global resolutions while ensuring sustainability and effectiveness.
  • Manage External Requirements change-impact assessment metrics and ensure changes to regulations, standards, and Abbott policies are implemented in a timely manner.
  • Serve as the primary interface with external regulatory bodies and manage internal and external inspections, audit strategies, and any required site responses.
  • Partner with peers and provide strategic leadership to other site functions to define and implement an effective audit-readiness program.
  • Drive key readiness initiatives using risk-based prioritization and mitigation to maintain audit-ready status.
  • Evaluate and monitor external and internal audit results, report results to management, and report the status and execution of corrective actions associated with audit results.
  • Analyze trends from various sources and proactively address regulatory, compliance, and quality issues.
  • Participate in FDA inspections and lead internal/corporate audits, notified body audits, and applicable external certification audits, including post-audit responses.
  • Assess published regulatory guidance, changes to standards, and Abbott policies; determine their impact and implement risk-mitigation strategies at the site as applicable.
  • Maintain an understanding of the business climate and relationships while implementing compliance-improvement initiatives and maintaining quality excellence.
  • Maintain data-analysis requirements for applicable Quality System metrics and Quality Management Reviews (QMRs).
  • Lead, guide, and retain a diverse, highly qualified staff; provide ongoing performance feedback; set goals aligned with business plans; and manage goal execution through coaching and mentoring.
  • Maintain a safe, enthusiastic, and professional work environment.
  • Comply with U.S. Food and Drug Administration regulations, other regulatory requirements, company policies, operating procedures, processes, and task assignments.

Desired Qualifications

  • Excellent communication, leadership, and analytical skills are preferred.
  • Attention to detail and a strong focus on regulatory compliance are preferred.
  • Ability to work independently and as part of a team is preferred.

About the Company

Abbott

Makes heart devices, glucose sensors and lab tests

Abbott makes medical devices, diagnostic tests, nutrition products and branded generic drugs for hospitals, laboratories, pharmacies and patients. Its best-known product is the FreeStyle Libre, a coin-sized sensor worn on the upper arm that tracks blood sugar around the clock without routine finger pricks. Its other lines run from heart valves, pacemakers and brain stimulators to lab analyzers, rapid tests and mail-in colon cancer screening kits, and Abbott earns money by selling these products to health systems, labs, retailers and consumers. The company was founded in 1888 by Chicago physician Wallace Abbott and is based in Abbott Park, Illinois.

Company size
10,001+
Company stage
IPO
Headquarters
Abbott Park, IL
Founded
1888

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