Quality Systems and ISO 13485 savvy Quality Manager sought for this newly created opening at this expanding diagnostic, life science and medical device company.
• Quality Systems development incorporating design and development through commercial.
• ISO 13485 certification and related gap assessment for 2016 revision
• Design Assurance oversight and DHF structuring
• Development of Complaint Management Systems and Supplier Quality programs
• Secure CE Mark
• Product release oversight
• Site training including QMS training development
• BS Degree in a Scientific or Engineering discipline
• 6+ years Medical Device experience with at least 3 recently in Quality
• Quality Systems development success
• Self-starting and team building capabilities
• Complaint systems management
Location/Geographic Area: Austin, TX
Relocation Eligible: Yes
Compensation: Base & Bonus.
Benefits: Yes (this is perm)
Contact: Apply at www.fpccareers.com and/or contact email@example.com