Principal Quality Systems Engineer - Supplier QA

Recruiter: Spencer Gregory Hale

 

 

Principal Quality Systems Engineer – Supplier QA

 

About This Role:

The Principal Quality Systems Engineer of material controls will serve as a Quality representative to improve awareness, visibility and communication on quality initiatives and objectives, and will support assigned departmental, functional, site, divisional and corporate quality goals and priorities.  Specifically, this role will support the Material (Supplier) controls processes, ensuring compliance to Medical Device regulations and BSC Quality System requirements.

 

Your Responsibilities Will Include:

• Leadership of cross functional projects teams
  • Using project management best practices to effectively coordinate activities, communicate progress, collaborate on key deliverables and meet critical phase timelines
  • Driving continuous improvement and globalization by gaining alignment across multiple functional departments while meeting BSC and regulation requirements
  • Communicating and Influencing across the BSC Global Sourcing organization to deliver long term strategic outcomes
• Providing continuous and rigorous assessment of Material Controls processes and review of documentation throughout the material controls processes to ensure compliance with global BSC processes, FDA regulations, ISO 13485, and Medical Device Requirements
• Ownership of highly visible, global, systemic CAPAs while leading through a Community of Practice
• Providing guidance to functional members and teams on in area of process ownership, such as supplier audit/AVL, material qualification, procurement, supplier change and corrective action through audit support and CAPA processes
• Determining and tracking actionable material controls metrics and trends to ensure proper execution and effectiveness of the global process
• Participates or leads in appropriate BSC Communities of Practice to ensure the global processes continuously executes process outputs at the highest industry/company level and anticipates emerging regulatory lines of questioning.
• Supporting both site and global scale CAPA initiatives, continuous improvement opportunities and/or projects

 

What We’re Looking For In You:

Minimum Qualifications

• Bachelor's degree and 5+ years or Masters degree and 3+ years of experience in a medical device manufacturing, quality or regulatory/compliance environment
• Previous experience in a Supplier Quality, Supplier Engineering, or Sourcing organization
• Understanding of quality system requirements as stated within 21 CFR Part 820 and ISO 13485
• Must be willing to travel 10% of the time
• Technical writing and documentation skills

 

Preferred Qualifications

• Degree(s) in Science or Engineering
• 5+ years of experience in Supplier Quality, Supplier Management, or Quality Systems
• Traini