QMS & Regulatory Compliance Specialist

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 115,000 colleagues serve people in more than 160 countries.


JOB DESCRIPTION:

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 St. Paul, MN location in the SH division.

Structural Heart Business Mission: Why We Exist.

Our business purpose is to restore health and improve quality of life by designing and providing device and management solutions for treating structural heart disease.

This position is responsible for supporting the development, implementation, and maintenance of the quality management system to ensure regulatory compliance and product quality. The position provides hands-on quality system support for commercialized products, new product development, manufacturing processes, and overall system compliance.

What You'll Work On

• Provide day-to-day support as a Quality Systems subject matter expert (SME), to ensure consistent application of QMS requirements across the organization.
• Lead and execute data analysis, systems evaluations, and product assessments to ensure compliance with established standards and specifications; proactively identify trends and implement improvements.
• Investigate, document, and resolve quality system nonconformances identified through internal and external audits, ensuring timely and effective corrective and preventive actions.
• Collaborate with product development and manufacturing teams to ensure quality deliverables (e.g., FMEA, Control Plans, Risk Management documentation) are established and compliant prior to design transfer phase gates.
• Support compliance with applicable regulatory requirements, including ISO 13485 and 21CFR 820 Quality System Regulations by interpretating regulations, conducting gap assessments, and leading remediation and continuous improvement activities.
• Apply structured, risk-based problem-solving methodologies to identify, prioritize, communicate, and resolve quality and compliance issues.
• Utilize continuous as appropriate, utilizes Six Sigma and other quality tools to implement process improvements to enhance product quality and reduce process variance by identifying improvement opportunities in divisional quality system compliance, device, and process.
• Analyze audit findings and quality metrics to recommend and implement improvements to processes, systems, and products standards.
• Lead or participate in cross-functional teams to support quality system initiatives, decision-making, and best practices across the product lifecycle.
• Support and/ or lead risk management activities related to quality systems, ensuring ongoing maintenance and compliance with applicable standards.
• Ensure adherence to FDA regulations, global regulatory requirements, company policies, and internal procedures.
• Maintain effective communication and collaboration with internal stakeholders, customers, contractors, and suppliers at all organizational levels.
• Performs additional duties as assigned.

Required Qualifications

• Bachelors Degree in Engineering or Technical Field or an equivalent combination of education and work experience.
• 2-5 years technical experience. Previous Quality experience and demonstrated use of Quality tools/methodologies.
• Detailed knowledge of FDA, GMP, and ISO 13485. Solid communication and interpersonal skills.
• Demonstrated and impactful project management and leadership skills, including the demonstrated ability to lead multi-departmental project teams and resolve quality system-related issues in a timely and effective manner.
• Advanced computer skills, including gap analysis and report writing skills.
• Ability to work in a highly matrixed and geographically diverse business environment.
• Ability to work within a team and as an individual contributor in a fast-paced, changing environment.
• Ability to leverage and/or engage others to accomplish projects.
• Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization.
• Multitasks, prioritizes and meets deadlines in timely manner.
• Strong organizational and follow-up skills, as well as attention to detail.
• Ability to travel approximately 10-25%, including internationally.

Preferred Qualifications

• Masters Degree.
• Prior medical device experience.
• Six Sigma certification.
• ASQ CQE, CQA certification.
• Experience working in a broader enterprise/cross-division business unit model.

Apply Now

Learn more about our health and wellness benefits, which provide the security to help you and your family live full lives:

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 on Facebook at and on Twitter @AbbottNews.

The base pay for this position is
$68,000.00 - $136,000.00
In specific locations, the pay range may vary from the range posted.

JOB FAMILY:
Engineering


DIVISION:
AVD Vascular


LOCATION:
United States > Minnesota > St. Paul : 1225 Old Highway 8 NW


ADDITIONAL LOCATIONS:

WORK SHIFT:
Standard


TRAVEL:
Yes, 15 % of the Time


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:


EEO is the Law link - Espanol: