Senior Manager Quality Compliance

Abbott • Plymouth, MN

1d • $129,300 - $258,700 • Onsite

About The Position

The Senior Manager Quality Compliance works at Abbott’s Plymouth, Minnesota location in the Electrophysiology (EP) division. The role provides leadership for quality-system compliance initiatives, audit readiness, regulatory change management, field actions, and compliance strategy across the EP business. It leads teams and partners across functions to strengthen compliance capabilities, support inspections and audits, and drive continuous improvement.

The position develops and executes global quality and compliance strategies aligned with divisional priorities; builds program roadmaps, business cases, budgets, funding requests, and implementation plans; and presents progress, risks, and recommendations to executive leadership. It advances the division’s Quality Management System, manages regulation and standards change activities, supports external certification requirements, and leads continuous improvement and risk-reduction efforts. It also supports critical quality events and field actions, develops organizational quality capabilities through mentoring and training, and monitors industry trends and emerging compliance risks.

Requirements

• Bachelor’s degree in Engineering, Life Sciences, Industrial Technology, or a related field.
• 13 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.
• Previous management experience.
• 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

• Lead quality compliance programs, including external audit support, inspection readiness, and quality-system effectiveness initiatives.
• Develop and execute compliance strategies for the EP business and strengthen audit capabilities across sites and functions.
• Lead and support the lifecycle of external audits, including preparation, execution, response management, completion, and follow-up.
• Drive inspection readiness across global sites for FDA, Notified Body, and other regulatory inspections.
• Identify compliance gaps with site and functional leaders, implement remediation plans, and sustain inspection-readiness programs.
• Manage Health Hazard Evaluation (HHE), Risk Review Evaluation (RRE), Software Risk Evaluation (SRE), field-action, and remediation activities.
• Develop field-action strategies and support implementation when required.
• Assess industry trends, regulatory changes, standards updates, and their impacts; coordinate implementation plans.
• Support certificate management, external certification requirements, and Finance Portfolio Management.
• Ensure effective implementation and governance of quality programs within the division’s Quality Management System.
• Build and manage program roadmaps, business cases, budgets, funding requests, and implementation plans for complex initiatives.
• Establish partnerships across Quality, Manufacturing, Regulatory Affairs, Supply Chain, and Commercial organizations.
• Present program strategies, progress, risks, and recommendations to executive leadership and stakeholders.
• 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; manage and communicate dashboards and executive-level reporting.
• Lead and mentor a diverse team and develop compliance capabilities across EP sites and functions.
• Mentor colleagues on compliant decision-making and quality best practices, and enhance capabilities through training, consultation, and knowledge sharing.

Benefits

• Career development opportunities with an international company.
• 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