Site Quality Leader

Abbott

Abbott seeks a Site Quality Leader for its Plymouth, MN structural heart manufacturing facility. This senior quality role drives regulatory compliance, oversees quality systems, and leads the quality organization as a key member of the site leadership team.

Responsibilities

Develop and implement site quality strategy aligned with business objectives and regulatory expectations
Represent quality on Site Leadership Team and embed quality principles into decision-making
Ensure full compliance with FDA QMSR, EU MDR, and ISO 13485 standards
Lead and develop the site quality organization and provide direction to quality staff
Establish quality and reliability standards through assessment of product requirements and risk analysis

Requirements

Bachelor's or advanced degree in Engineering or related field
Minimum 12 years medical device manufacturing experience with quality leadership roles
Comprehensive knowledge of FDA, EU MDR, and global regulatory requirements
Proven ability to lead and develop quality teams in medical device manufacturing
Expertise managing CAPA, change control, deviations, complaints, and document control
Experience conducting regulatory inspections and serving as quality interface with authorities
Strong written and verbal communication skills

Apply

Vacancy posted 1 day ago

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