Quality Engineer

Summary:

As a Quality Engineer will assist with the development of quality systems procedures and controls to ensure that all medical products consistently meet performance and quality specifications in the Germantown Manufacturing facility. The Quality Engineer is a leader and strong technical resource who quickly and effectively resolves quality problems with internal and external customers and suppliers

Below Are Additional Duties And Responsibilities

• Generates communicates and implements ideas and solutions.
• Demonstrates accuracy and thoroughness in completing tasks timely.
• Looks for ways to improve and promote quality.
• Monitor Corrective Action System (i.e. Customer Complaints Supplier Internal)
  • Initiate and investigate Customer Complaints according to MGS internal procedure and standards.
  • Record essential information on internal and/or customer-specific documentation including updating customer portals.
  • Perform investigations using Lean Six Sigma and statistical methods to support root cause analysis and corrective actions.
  • Identify gaps and/or trends in systems or processes.
  • Initiate and facilitate the Corrective/Preventative Action process using the appropriate quality tools and input from subject matter experts (SME) to implement sustainable solutions.
  • Update Quality documents according to MGS Change Control procedures as required.
  • Verify corrective action effectiveness.
• Drive Non-Conformance Process
  • Evaluate and investigate suspect non-conforming product identified by manufacturing and/or the Quality Lab.
  • Initiate containment activities as necessary with Customer Service and Shipping Department.
  • Recommend disposition of product based on thorough investigation and data-driven feedback.
  • Initiate and assist Customer Service with Return Material Authorization (RMA) process.
  • Develop re-inspection sort and/or rework instructions for Manufacturing Operators as required.
  • Collaborate with customer on issuing waiver or deviation documentation and obtain customer approval as required.
• Maintain the Quality Management System (QMS).
  • Understand ISO 13485 Quality management systems requirements.
  • Ensure continuing compliance to both internal MGS processes as well as requirements imposed upon MGS by certification bodies regulatory agencies and specific customer requirements.
  • Assist in internal 2nd party and 3rd party audits.
  • Assist with responses and corrective actions for audit findings.
• Support Product Realization process
  • Participate in design review process planning and failure mode analysis
  • Provide input on evaluation of Key Product Characteristics.
  • Provide input on gaging methods and equipment.
  • Interpret customer requirements including complex blueprints and GD&T call-outs.
• Review and approve Engineering Change Notifications and Verifications
  • Evaluate for feasibility and implement updates to customer requirements into associated product control plans pFMEA Inspection documentation and other related documents.
    • Incorporate industry standard best practices.
    • Incorporate MGS lessons learned.
  • Evaluate submit and track Supplier Change Notices to customers and/or suppliers.
  • Any other duties as assigned.
  • Manufacturing point of contact for the review and disposition of product quality related questions.
• Approve Medical Device release for shipment as required.
  • Perform batch record reviews for medical device prior to release for shipment.
  • Generate Certificate of Analysis as required.
  • Release product in ERP system based on customer and MGS process requirements.
• Support Manufacturing process
  • Train Manufacturing and Quality Control personnel on customer requirements inspection techniques lessons learned and rework instructions.
  • Manage product inspection and testing activities.
  • Obtain customer approvals for all required changes based on Quality Agreements.
  • Compile supporting measurement and process performance data as necessary
  • Assemble supporting documentation package and review for completeness and accuracy
  • Review and approve production documentation updates according to MGS Engineering Change Order process.

Required Experience

• BS in Engineering Quality or related technical field is preferred.
• Experience in a quality engineering role within a regulated manufacturing environment (medical device a plus).
• Understanding of quality standards and regulatory requirements: ISO 9001 ISOCFR Part 820.
• Understanding of best practices for cleanroom gowning and cleanliness requirements for manufacturing within a cleanroom.
• Experience with Microsoft Office products - Excel Word PowerPoint
• Greenbelt Certification is a plus.
• Demonstrated experience in driving continuous improvement projects and using quality tools (e.g. DMAIC 8D PFMEA SPC MSA DOE).
• Excellent interpersonal communication and presentation skills.
• GD&T experience is a plus.