The primary purpose of this role is to lead the manufacturing site or sites assigned to ensure they meet customer requirements while remaining in compliance with associated quality management system policies
Job Summary
The primary purpose of this role is to lead the manufacturing site or sites assigned to ensure they 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 supervisors, engineers, and individual performers to establish a culture of quality across the organization.
This role requires specialized knowledge of quality system regulations such as ISO 13485, ISO 9001, and Good Manufacturing Practices along with auditing experience.
Matching Summary
The primary purpose of this role is to lead the manufacturing site or sites assigned to ensure they meet customer requirements while remaining in compliance with associated quality management system policies.
Skills & Requirements
Must-have
ISO 13485 and ISO 9001 compliance
FDA regulations and 21CFR820 knowledge
Root cause analysis and CAPA management
Supplier quality audits and internal QMS audits
Team leadership and development of quality staff
Nice-to-have
Six Sigma Green Belt certification
ASQ Certified Manager of Quality
Experience with EU MDR regulations
Hoshin planning and strategic alignment
Positive can-do attitude in fast-paced environments
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 root cause analysis and statistical analysis
Familiarity with Test Method development and risk assessments