Quality Compliance Program Manager

Abbott • Plymouth, MN

4d • $99,300 - $198,700 • Onsite

About The Position

The Quality Compliance Program Manager works in Abbott’s Electrophysiology division in Plymouth, Minnesota. The role partners with leaders across manufacturing, quality, regulatory, and commercial functions to advance compliance initiatives, strengthen audit readiness, manage critical quality programs, and help shape the quality culture. Its areas of leadership include audit readiness, field actions, standards and regulation change management, certificate management, and data integrity initiatives.

The position develops and executes global quality and compliance strategies, manages complex program roadmaps and resources, and presents progress, risks, and recommendations to executive leadership. It leads audit and inspection readiness activities, supports quality management system governance, assesses regulatory and standards changes, drives compliance improvements and risk reduction, and supports field actions and related quality evaluations. The role also mentors colleagues, delivers training and consultation, and monitors industry trends and emerging compliance risks.

Requirements

• Bachelor’s degree in Engineering, Life Sciences, Industrial Technology, or a related field.
• 10 or more years of combined experience in Quality, Compliance, Manufacturing Operations, Regulatory Affairs, or related functions.
• Demonstrated experience leading large, cross-functional programs in a regulated industry.
• Strong knowledge of Quality Management Systems and compliance processes.
• Experience influencing stakeholders and driving results in a matrixed global organization.
• Excellent communication, presentation, and executive-facing leadership skills.

Nice To Haves

• Experience in the medical device, healthcare, pharmaceutical, or another highly regulated industry.
• Experience supporting FDA inspections, Notified Body audits, MDSAP, ISO standards, or related regulatory environments.
• International experience and/or foreign language proficiency.
• Experience with audit readiness programs, field actions, regulatory change management, and quality system governance.
• Strong analytical and business acumen, with the ability to connect compliance requirements to operational and business outcomes.

Responsibilities

• Develop and execute global quality and compliance strategies aligned with divisional priorities and long-term business objectives.
• Build and manage program roadmaps, business cases, budgets, funding requests, and implementation plans for complex, multi-workstream initiatives.
• Partner across Quality, Manufacturing, Regulatory Affairs, Supply Chain, and Commercial organizations to drive program execution.
• Present program strategies, progress updates, risks, and recommendations to executive leadership and key stakeholders.
• Lead and support external audit lifecycle activities, including preparation, execution, response management, and follow-up.
• Drive inspection readiness across global sites for FDA, Notified Body, and other regulatory inspections.
• Work with site and functional leaders to identify compliance gaps, implement remediation plans, and sustain inspection readiness programs.
• Ensure effective implementation and governance of quality programs within the division’s Quality Management System.
• Assess and manage the impacts of evolving global regulations, standards, and industry expectations.
• Own and coordinate standards and regulation change management, including impact assessments and implementation plans.
• Support certificate management and external certification requirements.
• Drive continuous improvement initiatives that enhance compliance effectiveness, operational efficiency, and quality performance.
• Identify opportunities to use technology, automation, analytics, AI-enabled solutions, training, and process improvements.
• Monitor quality metrics, program effectiveness, and compliance trends to proactively mitigate risk.
• Manage and communicate program dashboards and executive-level reporting.
• Provide leadership and support for field action strategies and implementation activities when required.
• Support Health Hazard Evaluation (HHE), Risk Review Evaluation (RRE), and Software Risk Evaluation (SRE) programs.
• Coordinate cross-functional management of quality records, communications, and closure activities.
• Mentor and advise colleagues on compliant decision-making and quality best practices.
• Strengthen compliance capabilities through training, consultation, and knowledge sharing.
• Monitor industry trends and emerging compliance risks to inform quality strategies and organizational readiness.

Benefits

• Career development opportunities with an international company.
• Eligible employees may qualify for free medical coverage in the Health Investment Plan (HIP) PPO medical plan in the next calendar year.
• Retirement savings plan with a high employer contribution.
• Tuition reimbursement.
• Freedom 2 Save student debt program.
• FreeU education benefit, offering an affordable and convenient path to a bachelor’s degree.
• Health and wellness benefits.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior