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:
Senior Manager Quality Compliance
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. You’ll also have access to:
- 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 Senior Manager Quality Compliance, you’ll provide leadership for quality system compliance initiatives, audit readiness, regulatory change management, field actions, and quality compliance strategy across the EP business. This role leads teams and collaborates across functions to strengthen compliance capabilities, support inspections and audits, and drive continuous improvement
What You’ll Work On
- 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.
Quality Management Systems/Compliance
- Support life cycle of external audits (ie. execution, preparation, completion, etc).
- Drive site audit readiness for FDA & NB
- Expand compliance capabilities to support IA
- Support Certificate Management and Finance Portfolio Management
- Manage HHE and Field Action Program
- Impact Analysis on Industry Trends
- Manage Field Action Strategy, as appropriate
- As needed, support regulation and standards change assessment
People Management & Strategy
- Lead diverse team to achieve compliance goals
- Develop compliance strategy for EP BU
- Develop audit capability across EP sites and functions
- Demonstrate Compliance Expertise through Leadership Behaviors
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.
- 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.
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
.
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
$129,300.00 – $258,700.00
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:
Yes, 15 % of the Time
MEDICAL SURVEILLANCE:
No
SIGNIFICANT WORK ACTIVITIES:
Keyboard use (greater or equal to 50% of the workday), Work in a clean room environment
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