Quality Compliance Program Manager

Abbott; Plymouth (MN); On-site; USD 99,000 - 199,000; Full time

Benefits offered by this job

Health coverage

Retirement plan

Tuition reimbursement

Education benefit

Job summary

Abbott is seeking a Quality Compliance Program Manager in Plymouth, MN to drive global quality and compliance initiatives across manufacturing, regulatory, and commercial functions. You will lead audits, improve systems, and guide cross-functional teams in a regulated environment.

The role emphasizes leadership, stakeholder influence, and a culture of quality with opportunities for career growth within a world-renowned health care leader.

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.
• Experience leading large, cross-functional programs in a regulated industry.
• Strong knowledge of Quality Management Systems and compliance processes.
• Experience influencing stakeholders in a global matrix organization.
• Excellent communication, presentation, and executive-facing leadership skills.

Responsibilities

• Lead strategic quality and compliance programs aligned with divisional priorities and long-term business objectives.
• Build and manage program roadmaps, budgets, and implementation plans for multi-workstream initiatives.
• Strengthen audit readiness and drive inspection success across global sites (FDA, Notified Bodies, etc.).
• Advance the global Quality Management System and governance within the division.
• Identify opportunities to leverage technology, analytics, and training to reduce risk and improve quality.

Education

Bachelor's degree

Job description

Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 122,000 colleagues serve people in more than 160 countries.

Job Description: Quality Compliance Program Manager

Working at Abbott At Abbott, you can do work that matters, grow, and learn, care for yourself and your family, be your true self, and live a full life.

Career development with an international company where you can grow the career you dream of.

Employees can qualify for free medical coverage in our Health Investment Plan (HIP) PPO medical plan in the next calendar year.

An excellent retirement savings plan with a high employer contribution.

Tuition reimbursement, the Freedom 2 Save student debt program, and FreeU education benefit - an affordable and convenient path to getting a bachelor’s degree.

A company recognized as a great place to work in dozens of countries worldwide and named one of the most admired companies in the world by Fortune.

A company that is recognized as one of the best big companies to work for as well as the best place to work for diversity, working mothers, female executives, and scientists.

The Opportunity

This position works out of our Plymouth, MN location in the Electrophysiology division, we're advancing the treatment of heart and vascular disease through breakthrough medical technologies, allowing people to restore their health and get on with their lives.

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.

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

Abbott is about the power of health. For more than 135 years, Abbott has been helping people reach their potential - because better health allows people and communities to achieve more. With a diverse, global network serving customers in more than 160 countries, we create new solutions - across the spectrum of health, around the world, for all stages of life. Whether it's next-generation diagnostics, life-changing devices, science-based nutrition, or novel reformulations, we are advancing some of the most innovative and revolutionary technologies in healthcare, helping people live their best lives through better health. The people of Abbott come to work each day with relentless energy, enthusiasm and a promise to enhance the health and well-being of millions of people. They push the boundaries to help manage and treat some of life's greatest health challenges. We invite you to explore opportunities at Abbott, to see if your talents and career aspirations may fit with our openings. An equal opportunity employer, Abbott welcomes and encourages diversity in our workforce.

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