Quality Compliance Leader — Audit Readiness & Strategy

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

Benefits offered by this job

Health coverage

Tuition reimbursement

Retirement plan

Education benefits

Career development

Diversity & inclusion

Job summary

Abbott, a global healthcare leader, seeks a Senior Manager Quality Compliance in Plymouth, MN to lead quality systems, audit readiness, and regulatory change management across the EP division. You will drive strategy, partner with functional leaders, and mentor teams to strengthen compliance across sites.

You will oversee external audits, field actions, and risk reduction initiatives while aligning with global standards.

Qualifications

• Bachelor's degree in Engineering, Life Sciences, Industrial Technology, or related field.
• 13+ years of combined experience in Quality, Compliance, Manufacturing Operations, Regulatory Affairs, or related functions.
• 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 global matrix organization.
• Excellent communication, presentation, and executive-facing leadership skills.
• Preferred: experience supporting FDA inspections, Notified Body audits, MDSAP, ISO standards, or related regulatory environments.

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.
• Support lifecycle of external audits (execution, preparation, completion, etc) and drive FDA & Notified Body inspection readiness.

Skills

Quality management

Regulatory compliance

Leadership

Cross-functional collaboration

Audit readiness

Communication

Education

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

Job description

Abbott, a global healthcare leader, seeks a Senior Manager Quality Compliance in Plymouth, MN to lead quality systems, audit readiness, and regulatory change management across the EP division. You will drive strategy, partner with functional leaders, and mentor teams to strengthen compliance across sites.

You will oversee external audits, field actions, and risk reduction initiatives while aligning with global standards.