Director of Quality 
Direct Hire
Pay is open Pending Experience 
Pittsburgh, PA

Blackrock Resources is looking for a Director of Quality for a client in the Pittsburgh, PA area. The right candidate will have a BS in science/engineering and 10 plus years’ experience in quality with 7 or more in a in a leadership role.

Required Skills and Experience

  • BS Degree in Science / Engineering with a preference to a Masters Degree
  • Hands on with the Implementing/Establishing a Quality Management System
  • Well-versed with 21 CFR 820, cGMP, ISO 13485 2016, ISO 9001 2015, IEC 62304, ISO 14971, MDSAP, CMDCAS, EU MDD/MDR, and other global medical device regulations
  • Excellent communication/presentation skills
  • Strong leadership and influencing skills to drive results in a highly matrixed organization
  • Experience with leading FDA and other agency regulatory inspections a plus
  • Experienced in transforming and improving Quality processes, systems and culture with a demonstrated track record of process and productivity improvement and successful results with developing and implementing change initiatives

Principal (Essential) Duties:

  • Ensure that the Quality Management System is established, implemented, and maintained in compliance with all relevant regulatory standards
  • Ensure that the Quality Management System supports current business priorities and improves upon it to enable and support the company's growth
  • Report and communicate to management on the performance of the quality management system and any needed improvements or quality issues
  • Manage a comprehensive internal auditing program and ensure that internal audits are performed no less than annually by an independent source
  • Manage and monitor the corrective and preventative action programs and customer complaint system
  • Perform or manage out of specification (OOS) investigations; initiate corrective actions when OOS results or data are encountered
  • Additional duties as needed.

If you are looking for a career with a growing company that is working on the new cutting edge technology and are qualified please send your resume to [email protected]

Attach a resume file. Accepted file types are DOC, DOCX, PDF, HTML, and TXT.

We are uploading your application. It may take a few moments to read your resume. Please wait!

Director of Quality