Supplier Quality and Manufacturing Engineer

• Supplier Quality Management: Supplier Change Requests (SCR), PPAP, validation, TMV, SCAPA, and Quality Management Systems (QMS).
• DFM&A and Manufacturing Processes: Strong knowledge of Design for Manufacturing and Assembly (DFM&A), plastics, metals, packaging components, and process qualification.
• Medical Device Quality & Compliance: Knowledge of ISO 13485, FDA 21 CFR Part 820, FMEAs, Control Plans, and Quality Plans.

Key Responsibilities

• Manage supplier quality activities for finished goods manufactured by contract manufacturers.
• Review and approve Supplier Change Requests (SCR), validations, TMV, PPAP, and quality documentation.
• Develop and maintain Quality Plans, Control Plans, FMEAs, and supplier quality systems.
• Apply DFM&A principles to improve manufacturing processes for plastics, metals, and packaging components.
• Evaluate project feasibility and identify opportunities for cost savings, improved efficiency, and quality enhancement.
• Perform root cause analysis and implement corrective and preventive actions.
• Support part and process qualification and ensure compliance with technical specifications and quality standards.
• Collaborate with suppliers, engineering, manufacturing, and global cross-functional teams.
• Track project progress, prepare reports, analyze data, and drive continuous improvement initiatives.

Required Qualifications

• Bachelor's degree in Mechanical Engineering, Production Engineering, or a related technical field.
• 9–12 years of relevant experience in quality engineering, supplier quality, manufacturing, or a related field.
• Strong expertise in DFM&A principles and manufacturing methods for plastics, metals, and packaging components and systems.
• Hands-on experience with PPAP, supplier quality processes, root cause analysis, and corrective actions.
• Proficiency in CAD tools such as Creo or Solid Works.
• Experience with PLM/PDM tools;
  Windchill is preferred.
• Strong project management skills, including planning, tracking, and cross-functional coordination.
• Proficiency in Microsoft Excel and PowerPoint for reporting, data analysis, and presentations.
• Excellent verbal, written, and presentation skills, including collaboration with global teams.
• Knowledge of medical device regulations, including ISO 13485 and FDA 21 CFR Part 820.