Engineer,Senior Quality

Leads efforts to improve or ensure quality through design and manufacturing of medical devices and components, manages quality, compliance and cost of medical devices and components, and acts as subject matter expert on elements within the quality department.

Requirements

• Ensures products and product changes comply with all specified regulatory agencies (FDA, ISO, UL, CSA, etc.).
• Creates and assists in developing, maintaining, and improving the Quality Management System (QMS) to ensure compliance to all specified regulatory agencies.
• Drives product quality improvements internally and externally by working with design, manufacturing, and supply chain.
• Acts as a technical lead, manages significant systems, uses strategic planning, and mitigates risk.
• Formulates solutions to complex and ambiguous problems that are not well defined.
• Communicates complex technical ideas through daily work, presentations, and workshops.
• Fosters cross team communication and knowledge sharing.
• Collaborates with teams and management to make critical technical decisions that align with organizational goals.
• Collaborates with leadership and other cross functional departments to align decisions with organizational goals.
• Champions six sigma techniques and drives standardization through continuous process improvement.
• Identifies and manages Six Sigma projects internal and external to the quality department as well as suppliers.
• Provides leadership, coaching, and/or mentoring to the co-op group and level I, II & III engineers.
• Supports, leads, or manages front room and/or back room for internal and external QMS audits and/or investigations.
• Teaches and provides guidance on engineering documentation such as engineering drawings, bill of materials, change orders, testing documents and DHF/DMR records.

Benefits

• Paid time off
• 401k matching
• Retirement plan
• Six sigma training and certification