Senior Site Quality Leader MedTech & Regulatory

Thornton Tomasetti

Plymouth (MN)

On-site

USD 149,000 - 299,000

Full time

4 days ago

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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.

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.