Site Quality Leader

Thornton Tomasetti; Plymouth (MN); On-site; USD 149,000 - 299,000; Full time

Benefits offered by this job

HIP medical coverage

Retirement plan

Tuition reimbursement

Job summary

Abbott in Plymouth, MN is seeking a Site Quality Leader to serve as the senior quality authority for the site, ensuring all products meet global regulatory requirements and Abbott Structural Heart Quality System. You will establish and lead the quality strategy, drive regulatory compliance, and maintain the finished devices and components quality system across Minnesota facilities.

You will lead the site quality organization, collaborate with leadership, participate in site governance, drive

Qualifications

• Bachelor’s degree in Engineering or related field is required.
• Minimum 12 years of medical device manufacturing experience with quality leadership.
• Comprehensive understanding of FDA, EU MDR, and global regulatory requirements.
• Experience leading and developing quality teams in a medical device setting.
• Proven ability to manage CAPA, change control, deviations, and document control.
• Experience managing regulatory inspections, customer audits, and serving as primary quality interface with authorities.
• Strong written and verbal communication skills.
• Ability to collaborate effectively across all organizational levels.

Responsibilities

• Establish and implement a site quality strategy aligned with regulatory expectations.
• Represent Quality on the Site Leadership Team and integrate quality into site decisions.
• Lead audits and regulatory inspections and drive continuous improvement.
• Provide quality oversight for Structural Heart manufacturing processes.
• Lead and develop the site quality organization and its budget.
• Provide quality oversight for Structural Heart manufacturing processes.
• Lead and develop the site quality organization.

Skills

Regulatory compliance

Quality leadership

CAPA management

FDA MDR knowledge

Regulatory inspections

Cross-functional collaboration

Education

Engineering degree

Job description

JOB DESCRIPTION:

WORKING AT ABBOTT:

At Abbott, you can do work that matters, grow, and learn, care for yourself and 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
• Free medical coverage for employees* via the Health Investment Plan (HIP) PPO
• An excellent retirement savings plan with 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 around the world 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 a best place to work for diversity, working mothers, female executives, and scientists

The Opportunity

The Site Quality Leader is the senior quality authority for the site and a key member of the Site Leadership Team. The role is accountable for ensuring that all products manufactured, tested, and released from the Plymouth, MN and St. Paul, MN Structural Heart facilities meet global regulatory requirements and conform to the Abbott Structural Heart Quality System. In addition, the position is responsible for establishing and leading the quality strategy, driving regulatory compliance, and maintaining the Quality Management System for finished Structural Heart devices and components manufactured at Minnesota facilities.

• Establish and implement a site quality strategy aligned with business objectives and regulatory expectations
• Represent Quality on the Site Leadership Team and embed quality principles into site decision making
• Promote a proactive quality culture focused on risk management, compliance, and continuous improvement
• Ensure full compliance with global regulatory standards including EU MDR, FDA QMSR, ISO 13845
• Maintain continuous inspection readiness and lead regulatory inspections
• Provide quality oversight for Structural Heart manufacturing processes
• Lead and develop the site quality organization

Location: Plymouth, MN

What You’ll Work On

• Develop and participate in setting quality assurance strategies and regulations
• Assess and advise on potential risks, ensures compliance and gives recommendations
• Take responsibility for all quality control aspects of the process (e.g., testing, operations, raw materials, production, finished products or services)
• Lead audits and regulatory inspections
• Establish quality and reliability standards by studying product and consumer requirements with other members of management and production operators, technicians, and engineers
• Establish standards for the disposition of finished products by devising evaluation tests, methods, and procedures
• Establish rework standards by devising inspection and physical testing methods and procedures.
• Foster a diverse workplace that enables all participants to contribute to their full potential in pursuit of organizational objectives
• Provide directions to managers, exempt specialists and non-exempt support in various areas, groups and/or operations
• Keep the organization's vision and values at the forefront of decision making and action
• Build strategic partnerships to further departmental and organizational objectives
• Interact internally and externally with executive-level management, outside regulatory agencies, customers, vendors and/or suppliers
• Coordinate across functional areas, business units, and/or geographies to achieve company or area goals
• Monitor and ensure compliance with company policies and procedures (e.g., compliance with FDA, BSI, EEO regulations, etc.).
• Make and execute operational decisions with a strategic perspective
• Direct and control the activities and budget of one or more functional areas, divisions, product groups and/or operations
• Review, analyze and present to senior staff and other groups the effectiveness of the Quality System
• Recommend and implement changes to the Quality System because of changing regulations and/or business needs
• Analyze data, make decisions or provide recommendations to senior staff regarding quality-related crises (e.g. patient injury due to product malfunction)
• Communicate quality policies, strategies and procedures to the organization through written documents, presentations and discussions

Experience You'll Bring

Required Qualifications

• Bachelor's or advanced degree in Engineering or related field
• Minimum 12 years of Medical Device manufacturing experience including significant quality leadership roles
• Comprehensive understanding of FDA, EU MDR, and global regulatory requirements
• Proven experience leading and developing quality teams in a medical device manufacturing environment
• Expertise in managing quality systems including CAPA, change control, deviations, complaints, and document control
• Experience managing regulatory inspections, customer audits, and serving as primary quality interface with authorities
• Strong written and verbal communication skills
• Ability to collaborate effectively across all organizational levels

Preferred Qualifications

• Strong understanding of risk management methodologies and quality tools
• Proficiency in root cause analysis and implementation of corrective actions
• Expertise in validation, qualification, and computer system compliance
• Experience implementing continuous improvement initiatives in a medical device manufacturing setting

The base pay for this position is $149,300.00 – $298,700.00 In specific locations, the pay range may vary from the range posted.

JOB FAMILY: Operations Quality DIVISION: SH Structural Heart LOCATION: United States > Minnesota > Plymouth : 5050 Nathan Lane N

WORK SHIFT:

Standard

TRAVEL:

Yes, 5 % 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: 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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