New · posted Oct 14
Abbott · Medical Devices
Site Quality Leader
- Plymouth, MN
- On-site
- Full-time
- Director
Closes Dec 31, 2026 · 79 days left
The role
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
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.
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
What you need
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 Qualificationsnice to have
- 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
What you'll do
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
Pay and benefits
$149,300 – $298,700 a year
Employer providedThe base pay for this position is
$149,300.00 – $298,700.00
In specific locations, the pay range may vary from the range posted.
Free medical coverage via Health Investment Plan (HIP) PPO
Retirement savings plan with high employer contribution
Tuition reimbursement
Freedom 2 Save student debt program
FreeU education benefit
Career development
Where you'll work
Plymouth, MNOn-siteOpen in Maps (opens in a new tab)
More jobs in Plymouth, MNWorking conditions
Standard
TRAVEL
Yes, 5 % of the Time
MEDICAL SURVEILLANCE
No
JOB FAMILY
Operations Quality
DIVISION
SH Structural Heart
LOCATION
United States > Minnesota > Plymouth : 5050 Nathan Lane N
Equal opportunity, accessibility and legal noticesAbbott's statements, word for word
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.pdfEEO is the Law link - Espanol: http://webstorage.abbott.com/common/External/EEO_Spanish.pdf
Job intelligence
The context around this role
Live data · October 14, 2026
Salary intelligence
How the pay compares
This role's midpoint is 6% above the US median for Quality Assurance roles at this level.
This roleEmployer provided
Director roles in the US65 roles publishing pay
| Annual base pay | Low | Median | High |
|---|---|---|---|
| This role | $149,300 | — | $298,700 |
| All US (middle half) | $186,000 | $211,000 | $231,500 |
This role: Abbott's own published range. Comparisons: the base pay employers published on open Quality Assurance roles at the same level on Regulatory Jobs, October 14, 2026. Nothing is estimated.
Career trajectory
Where this role sits in Quality Assurance
The general path across 598 open Quality Assurance roles on Regulatory Jobs, with the titles they carry most. Not Abbott's own promotion track.
Career resources on Quality Assurance
Skills DNA
What this role leans on
How many of the posting's 49 duty, requirement and summary lines touch each area. The posting's emphasis, not a proficiency score.
- GMP and compliance12
- Collaboration and leadership11
- Quality systems and risk8
- Documentation and SOPs5
- Lab testing and methods4
- Investigations and CAPA2
- Regulatory submissions2
- Validation and qualification1
- Data and digital systems1
Regulatory intelligence
The rules behind this role
Frameworks and standards this posting's work falls under, matched from its own words, each linked to the official source.
Company hiring pulse
Abbott on Regulatory Jobs
- 76
- Open roles
- 71
- Distinct roles
- 30
- Locations
By discipline
- Quality50 66%
- Regulatory24 32%
- Compliance & Safety2 3%
By level
- Senior & Principal38 50%
- Associate & Specialist21 28%
- Manager14 18%
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Site Quality Leader at Abbott
Applications close December 31. $149K–$299K a year, employer provided.