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
Vacancy posted 3 days ago
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