Not specified (assumed onsite or hybrid based on industry norms).
8+ years manufacturing experience
Iso 13485 and iso 9001 knowledge
Fda 21 cfr 820 regulatory compliance
Integer is seeking a Sr. Quality Manager to lead quality assurance efforts in a manufacturing environment focused on medical devices. The ideal candidate will have significant experience in quality management systems, regulatory compliance, and team leadership, contributing to the company's commitment to customer success and innovation
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 the associated quality management system policies and procedures.
You will provide leadership for a team of Quality function professionals, including any combination of Quality Supervisors, Quality Engineers, and individual performers, establishing a culture of quality across the site.
This role requires specialized knowledge with respect to quality system regulations such as EU MDR, ISO 13485, ISO 9001, Good Manufacturing Practices 21CFR820, and auditing experience.
Matching Summary
Match Score: 85
Integer is seeking a Sr. Quality Manager to lead quality assurance efforts in a manufacturing environment focused on medical devices. The ideal candidate will have significant experience in quality management systems, regulatory compliance, and team leadership, contributing to the company's commitment to customer success and innovation.
Skills & Requirements
Must-have
8+ years manufacturing experience
ISO 13485 and ISO 9001 knowledge
FDA 21 CFR 820 regulatory compliance
Root cause analysis and CAPA leadership
Team leadership and development
Supplier quality audits management
Nice-to-have
Six Sigma Green Belt certification
ASQ Certified Manager of Quality
Master's degree in engineering
EU MDR experience
Hoshin planning participation
Diverse and inclusive culture champion
Key Requirements
Bachelor's degree in engineering or related technical field
Minimum 8 years of experience in manufacturing environment
Prior supervisory or leadership experience required
Knowledge of ISO standards governance and regulatory compliance
Experience with design control and production control processes