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Integer is seeking a Sr. Quality Manager to lead quality management efforts at their manufacturing sites, ensuring compliance with regulatory standards and driving continuous improvement. The ideal candidate will have significant experience in a manufacturing environment, particularly with ISO standards, and demonstrate strong leadership skills.
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Job Summary
The primary purpose of this role is to lead the manufacturing site or sites assigned to ensure they meet and continue to meet customer requirements while remaining in compliance with associated quality management system policies.
You will provide leadership for a team of Quality function professionals including Quality Supervisors, Quality Engineers, and individual performers while establishing a culture of quality across the site.
This role requires specialized knowledge of quality system regulations such as EU MDR, ISO 13485, ISO 9001, and Good Manufacturing Practices along with auditing experience.
Matching Summary
Match Score: 75
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Integer is seeking a Sr. Quality Manager to lead quality management efforts at their manufacturing sites, ensuring compliance with regulatory standards and driving continuous improvement. The ideal candidate will have significant experience in a manufacturing environment, particularly with ISO standards, and demonstrate strong leadership skills.
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Skills & Requirements
Must-have
8+ years manufacturing experience
ISO 13485 and FDA 21CFR820 knowledge
Root cause analysis and CAPA leadership
Supplier quality audit experience
Team leadership and development
Design control and validation protocols
Nice-to-have
Six Sigma Green Belt certification
ASQ Certified Manager of Quality
EU MDR regulatory knowledge
Hoshin plan strategic alignment
Diverse and inclusive culture champion
Fast-paced decision making ability
Key Requirements
Bachelor's degree in engineering or related technical field
Minimum 8 years experience in manufacturing environment
Prior supervisory or leadership experience required
Knowledge of ISO standards governance and regulatory compliance
Experience with Test Method development and risk assessments