Manager, Quality Assurance

Abbott•Atlanta, GA

8d•Onsite

About The Position

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 115,000 colleagues serve people in more than 160 countries. 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. 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.

Requirements

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.

Nice To Haves

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.

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.