Quality Manager Jobs

About The Position

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
• 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.

Benefits

• 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.