Find Jobs
Make your next engineering career move with SoloPoint.
SoloPoint Solutions, Inc.
https://www.solopointsolutions.com/wp-content/uploads/2021/05/JB-Square-200x200-1.png
https://www.solopointsolutions.com
https://www.solopointsolutions.com
USD
160000.00
175000
YEAR
true
Director of Quality
2023-12-01
2024-01-19
Employment Type:
Direct
Category: Quality Manager
Job Number: 9722
Pay Rate: $160,000.00 - $175,000
Job Description
Qualifications:
- Bachelor’s Degree in Mechanical, Manufacturing, or Industrial Engineering preferred
- Ideal candidate will have 8+ years of industry experience in quality or regulatory role. At least 4 years of experience in the medical device industry
- Certified Quality Auditor
- Previous experience hosting FDA, ISO 13485, ISO 9001, and clean room audits
- Experience with Design History Reviews, Lot Reviews, etc.
- Experience with sending products out for sterilization with ETO and if possible also other methods such as X-ray and E-Beam
- Strong communication and negotiation skills
Responsibilities:
- Manage and update QMS according to customer requirements and maintain compliance with ISO 13495, 21CFR820
- Serve as regulatory expert to existing and prospective clients; demonstrate expertise in medical standards, manufacturing, and compliance with regulatory bodies
- Manage suppliers to ensure compliance standards are met
- Collaborate with internal team and vendors on solutions to timeline issues and changes in customer requests
- Serve as representative for quality audits and inspection by competent authorities, notified/regulatory bodies, customers, and other third parties. Audits include manufacturing lines and clean rooms.
- Consult clients on how manufacturing can be done efficiently and compliance with quality standards
- Create reports on performance of quality system and advise on improvements to be made