Provides leadership in managing, reviewing, analyzing and resolving supplied products and services quality issues. Leads the team responsible for primary Quality contact with suppliers and is responsible for assessment of new suppliers, monitoring the performance of existing suppliers, requalifying suppliers, and the effectiveness of the Quality System for managing the supplier base. Provides daily supervision of Supplier Quality team and leads staffing activities. Supports supplier selection, development and audit process through monitoring, review and quality analysis of the supplier selection process. Oversees the development of incoming materials inspection criteria for incoming quality assurance and inspection sampling plans for selected parts.
• Maintains supplier audit processes and procedures. Manages the performance of onsite supplier quality audits in support of cGMP compliance procedures.
• Oversees, or provides direct support for onsite supplier selection activities and capability studies.
• Coordinates with internal commodity teams to develop and deploy robust commodity strategies.
• Oversees the development of quality systems expertise with suppliers (e.g., statistical process control support, capability studies).
• Establishes policies and procedures that govern the development of inspection technicques incorporated in incoming quality inspection. Continuously monitors inspection effectiveness.
• Leads the resolution of supplier quality issues detected at incoming inspection and/or on the production line. Provides team leadership for projects/investigations relating to supplier quality issues.
• Manages the execution of the supplier corrective action request (SCAR) system.
• Facilitates resolution of internal/external material quality issues by participating in root cause analysis and by working with suppliers to monitor corrective action. Supports internal corrective action and material validation teams, as required.
• Provides information to suppliers and internal organizations through written and verbal presentations/reports.
• Manages the training and direction of supplier quality engineers and supplier quality analysis.
• Ensures compliance and audit readiness of assigned supplier quality files.
• Maintains and approves AVL supplier status.
• Reports on supplier performance via routine, defined metrics.
• May lead or assist in supplier development/improvement projects.
• Other related duties as required.
• Bachelor of Science (degree in Electrical or Mechanical Engineering preferred)
• Minimum 3 years of experience supervising a team of quality professionals
• Experience with current Supplier Quality methods and tools
• Excellent analytical, technical writing and verbal communication skills
• Knowledge of FDA and ISO requirements
• Certified Quality Auditor (CQA) certificate and/or Certified Quality Engineer (CQE) certificate strongly desired
• Additional study in quality sciences and business management disciplines
• Knowledge of quality improvement tools, including statistical methods
• Experience with PPAP (Production Part Approval Process) requirements, tools, processes, and deployment.
• Knowledge of metrology: specifically equipment selection, qualification and Gage R&R.
• Domestic and international travel (20-40%)
• Significant use of standard office equipment, including computer keyboard, monitor, and mouse
• Ability to lift up to 35 pounds
Physio-Control, Inc. - 6 months ago
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