$150,000 - $220,220; not specified; comprehensive ...
Quality management system leadership
Capa and complaint handling
Supplier quality audits
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
Job Summary
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 are responsible for the entirety of the local quality management system which includes but is not limited to Management Review, CAPA, Complaint Handling, Document Change Management, Design Control, Production control, internal and Customer nonconformance management, Supplier Quality Audits, and Internal QMS Audits.
Our compensation program includes base salary and a cash-based incentive program supporting our pay-for-performance philosophy.
Matching Summary
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.
Salary
$150,000 - $220,220; Not specified; Comprehensive benefits package
Skills & Requirements
Must-have
Quality Management System leadership
CAPA and Complaint Handling
Supplier Quality Audits
Internal QMS Audits
Root Cause Analysis
Process Improvement
Nice-to-have
Team leadership and development
Cross-functional consensus building
Diverse and inclusive work environment
Fast-paced and complex environment
Positive can-do attitude
Key Requirements
Bachelor's degree in engineering or related technical field
8+ years manufacturing experience with ISO/regulatory compliance
Prior supervisory or leadership experience
Quality specific certifications (e.g., Six Sigma Green Belt)
Knowledge of EU MDR, ISO 13485, ISO 9001, 21CFR820
Experience with Test Method development, Validation Protocols, Risk Assessments