Manager, Quality

Abbott • Plano, TX

1d • Onsite

About The Position

The Quality System Manager is responsible for developing, maintaining, and continuously improving the company’s Quality Management System (QMS) to ensure compliance with FDA 21 CFR Part 820, ISO 13485, and applicable global regulatory requirements. This role serves as the quality system owner and partners cross‑functionally to drive compliance, inspection readiness, and quality culture.

Requirements

• A Bachelor’s degree or an equivalent combination of education and work experience
• 5+ years of relevant work experience in quality
• Ability to monitor progress of exempt individuals, teams, supervisors or nonexempt technical individuals toward departmental goals
• Willingness to perform this job in a quality system environment. Failure to adequately perform tasks can result in noncompliance with governmental regulations
• Ability to develop and/or identify new work processes and the improved utilization of human and material resources within the assigned area or related departments; facilitates others involvement in the continuous improvement program
• Ability to investigate and solves problem that impact work processes and personnel within the assigned unit

Nice To Haves

• Solid knowledge of FDA regulations and guidelines and a deep understanding of medical device industry
• Strong analytical, organizational, and problem‑solving skills
• Previous work experience with external audits and CAPAs.

Responsibilities

• Implements a staffing plan by identifying resource requirements, writing justifications for additional personnel, obtaining approval for changes, and coordinating the selection process with Human Resources.
• Develops direct reports by securing appropriate training, assigning progressively challenging tasks, applying progressive disciplinary action as appropriate and conducting formal written and verbal performance reviews.
• Monitors daily work operations and provides direction and guidance to, experienced exempt employees, or skilled nonexempt staff to achieve unit or project goals.
• Serve as the process owner for the Quality Management System aligned with FDA QSR, ISO 13485, and company procedures
• Ensure QMS effectiveness, compliance, and sustainability across all operational areas.
• Monitors compliance with company policies and procedures (e.g. compliance with FDA, BSI, EEO regulations etc).
• Lead QMS updates in response to regulatory changes, internal findings, or business growth
• Lead and represent the QMS at internal and external audits, including FDA, ISO, Notified body.
• Demonstrates confidence and leadership during audits and inspections, representing the quality system with credibility and clarity.
• Owns CAPA process and CAPA monitoring.
• Drive continuous improvement initiatives across the QMS.
• Identifies, develops and implements processes to improve department performance.
• Implements improvements to Quality Systems and tools by directing personnel to gather data on existing quality tools, identify weaknesses, and research/select new tools based on findings.
• Establish, monitor, and trend QMS metrics and key performance indicators (KPIs).
• Trend quality system metrics and present data to management.
• Promote a culture of proactive compliance, accountability, and continuous improvement
• Monitors departmental activities and records to ensure compliance independent action through critical decision making.
• Ensures sustaining support of Quality System by individually working quality system issues and by delegating project work for maintaining quality system capability.
• Other responsibilities as needed.
• Promotes the attainment of group goals by selecting, motivating, and training capable staff
• Leads through influence, partnering cross‑functionally to embed quality system requirements into daily operations.
• Champions a culture of quality and accountability across the organization.
• Proactively drives alignment between business objectives and regulatory requirements.

Benefits

• 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Manager
• Number of Employees: 5,001-10,000 employees