Quality Engineer

Pay Range: $73,100.00 - $

Responsible for supporting Quality Engineering requirements for change control, continuous improvement, and customer complaints handling and satisfaction. Serves as a subject matter expert and liaison between the company and customers to resolve quality and manufacturing issues and ensure positive communication channels.

• Key member of complaint and MRB investigation teams; analyze, identify, develop, and implement manufacturing/production/process improvements to improve capability and/or performance.
• Own the change control process: perform risk assessment, facilitate change control plan writing/execution, monitor implementation, and close plans timely.
• Implement and validate a new electronic Quality Management System.
• Prepare quality information and trending data for management review.
• Enable positive internal and external communication to ensure customer satisfaction.
• Participate in internal, customer, and third-party audits.
• Other duties as assigned.

• BS in Quality, Biology, Chemistry, or similar.
• 2+ years’ experience as a Quality professional in a manufacturing environment.
• Diagnostics, pharmaceutical, or biological products manufacturing environment preferred.
• Proficient in ISO 13485.
• Auditing, Six Sigma, and Lean Manufacturing experience a plus.

• Prioritize multiple tasks effectively.
• Identify and solve problems; develop innovative solutions; act decisively with good judgment.
• Handle situations diplomatically.
• Excellent communication/interpersonal skills; strong organization; self-directed; effective at all organizational levels.
• Strong computer skills (Word, Excel, PowerPoint);
  Access database experience a plus.