Senior Manager, Quality Compliance – Electrophysiology

Abbott; Plymouth (MN); On-site; USD 129,000 - 259,000; Full time

Benefits offered by this job

Free medical coverage (HIP PPO)

Generous retirement plan

Tuition reimbursement

FreeU education benefit

Job summary

Abbott in Plymouth, MN is seeking a Senior Manager Quality Compliance in the Electrophysiology (EP) division. You will lead quality systems, regulatory readiness, and compliance strategy across EP, guiding cross-functional teams to strengthen audits and field actions.

You will drive programs, coordinate with Manufacturing, Regulatory Affairs, Supply Chain, and Commercial entities, and mentor staff to sustain a high standard of quality and regulatory excellence.

Qualifications

• Bachelor's degree in Engineering, Life Sciences, Industrial Technology, or a related field.
• 13+ 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.

Responsibilities

• Lead quality compliance programs, including external audit support, inspection readiness activities, and quality system effectiveness initiatives.
• Develop and execute compliance strategies for the EP business, strengthening audit capability across sites and functions.
• Manage and support Health Hazard Evaluation (HHE), RRE/SRE, field action, and remediation activities to ensure timely and compliant execution.
• Assess industry trends, regulatory changes, and standards updates, implementing solutions that advance organizational compliance.
• Lead and mentor team members while partnering with leadership and cross-functional stakeholders to achieve compliance objectives.

Skills

Quality management

Regulatory expertise

Cross-functional leadership

Stakeholder management

Executive communication

Project leadership

Management experience

Regulatory inspections

Education

Bachelor's degree in Engineering, Life Sciences, Industrial Technology, or related field

Job description

Abbott in Plymouth, MN is seeking a Senior Manager Quality Compliance in the Electrophysiology (EP) division. You will lead quality systems, regulatory readiness, and compliance strategy across EP, guiding cross-functional teams to strengthen audits and field actions.

You will drive programs, coordinate with Manufacturing, Regulatory Affairs, Supply Chain, and Commercial entities, and mentor staff to sustain a high standard of quality and regulatory excellence.