As the Quality Compliance Program Manager, you will partner with leaders across manufacturing, quality, regulatory, and commercial functions to drive key compliance initiatives, strengthen audit readiness, manage critical quality programs, and influence the future of our quality culture. The role also includes leadership of audit readiness, field actions, standards and regulation change management, certificate management, and data integrity initiatives
What You’ll Work On
Lead Strategic Quality & Compliance Programs
Develop and execute global quality and compliance strategies that align 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.
Establish meaningful partnerships across Quality, Manufacturing, Regulatory Affairs, Supply Chain, and Commercial organizations to drive successful program execution.
Present program strategies, progress updates, risks, and recommendations to executive leadership and key stakeholders.
Strengthen Audit Readiness & Inspection Success
Lead and support the lifecycle of external audits, including preparation, execution, response management, and follow-up activities.
Drive ongoing inspection readiness across global sites, including preparedness for FDA, Notified Body, and other regulatory inspections.
Partner with site and functional leaders to identify compliance gaps, implement remediation plans, and sustain inspection readiness programs.
Advance the Global Quality Management System
Ensure effective implementation and governance of quality programs within the division's Quality Management System.
Assess and manage impacts of evolving global regulations, standards, and industry expectations.
Own and coordinate standards and regulation change management activities, including impact assessments and implementation plans.
Support certificate management activities and external certification requirements.
Lead Compliance Improvement & Risk Reduction Efforts
Drive continuous improvement initiatives that enhance compliance effectiveness, operational efficiency, and quality performance.
Identify opportunities to leverage technology, automation, analytics, AI-enabled solutions, training programs, and process improvements.
Monitor quality metrics, program effectiveness, and compliance trends to proactively mitigate risk.
Manage and communicate program dashboards and executive-level reporting.
Support Critical Quality Events & Field Actions
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 to ensure timely completion and compliance.
Coordinate cross-functional teams to effectively manage quality records, communications, and closure activities.
Develop a Culture of Quality
Mentor and advise colleagues across the organization on compliant decision-making and quality best practices.
Enhance organizational compliance capabilities through training, consultation, and knowledge sharing.
Monitor industry trends and emerging compliance risks to help shape future quality strategies and organizational readiness.
Required Qualifications
Bachelor's degree in Engineering, Life Sciences, Industrial Technology, or a related field.
10+ 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.
Preferred Qualifications
Medical device, healthcare, pharmaceutical, or other highly regulated industry experience.
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.
Apply Now
Learn more about our health and wellness benefits, which provide the security to help you and your family live full lives: https://abbottbenefits.com/
Follow your career aspirations to Abbott for diverse opportunities with a company that can help you build your future and live your best life. Abbott is an Equal Opportunity Employer, committed to employee diversity.
Connect with us at abbott.com, on LinkedIn at https://www.linkedin.com/company/abbott-/, and on Facebook at https://www.facebook.com/AbbottCareers.
- The base pay for this position is
- $99,300.00 – $198,700.00
- In specific locations, the pay range may vary from the range posted.
JOB FAMILY
Operations Quality
DIVISION
EP Electrophysiology
LOCATION
United States > Minnesota > Plymouth : 5050 Nathan Lane N
ADDITIONAL LOCATIONS
WORK SHIFT
Standard
TRAVEL
No
MEDICAL SURVEILLANCE
No
SIGNIFICANT WORK ACTIVITIES
Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day), Keyboard use (greater or equal to 50% of the workday)
Abbott is an Equal Opportunity Employer of Minorities/Women/Individuals with Disabilities/Protected Veterans.
EEO is the Law link - English: http://webstorage.abbott.com/common/External/EEO_English.pdf
EEO is the Law link - Espanol: http://webstorage.abbott.com/common/External/EEO_Spanish.pdf
