Director or Vice President of Quality Assurance & Regulatory Compliance
January 30, 2018
90000.00 - 130000.00
Full Time - Experienced
4 Year Degree
A challenging role directing a diverse team including managing 6 direct reports: The experienced staff includes 2 manufacturing QA departments, Product Investigation team, Audit, CAPA, Nonconforming materials, calibration, document control, data analysis, management review, Supplier Quality, complaint handling, adverse event reporting, recalls, quality software validation, process validation, and more. This individual must exhibit leadership abilities and also be able to work alongside this dedicated quality team to achieve a best-in-class quality system. Our policy includes making defect free product, achieving on-time delivery, continuous improvement and satisfying our customers. We believe in “Quality Without Compromise”.
Minimum of 7 years experience in medical device
Minimum of 5 years experience in industrial manufacturing environment
4 year degree in a scientific or Engineering discipline required,
Experience in dealing with the FDA directly (front room)
Audit certifications in ISO 9001 and 13485 (at least one)
Knowledgeable of FDA Quality System Regulations 21 CFR Part 820
Leadership experience required, must currently manage at least 3 direct reports
Previous responsibility for Customer Complaint and MDR process preferred
Previous CAPA Management
Master’s degree or MBA preferred
Experience with CNC machining
Personal characteristics necessary for success:
Tenacity, direct but tactful nature, decisiveness, ethical, flexibility, ability to gain consensus, team building, passionate, persistent, patient, and assertive.
Additional Salary Information: annual salary
Internal Number: Quality333
About Western Enterprises
Western Enterprises - Medical Device Manufacturer
For more than 60 years, Western has been supplying products for the control, storage and transmission of high-pressure gases to the industrial, medical and specialty gas markets–and leading the field in the ways that matter most. Western is dedicated to be the best provider of compressed gas systems and components.