Quality Engineer

This position reports directly to the Quality Assurance Manager. This person will need to be confident in working on cross-functional teams and serve as a key technical resource in product support, document development, Quality compliance, maintenance of the document database, and as a Super User for both company sites. 

• Non-Conforming Material disposition
• Collects data from returns and NCRS for trending analysis
• Coordinates GEMBA meetings
• Works with manufacturing engineering to ensure necessary process controls are in place for design changes.
• Quality Trainer for Inspectors
• Helps lead to Root Causes for CAPA responses
• Liaison between Supplier regarding quality issues
• Participates in Internal audits
• Contribute to the design, development, and implementation of product quality assurance plans providing feedback on corrective and preventative actions to engineering, manufacturing, service, and field operations and supplier performance

1. Oversees all customer returns (OOBF, Warranty, Complaints, etc.)
2. Failure Analysis of Returns
3. Quality Team Lead
4. Quality Subject Matter Expert for all Quality areas
5. Supports Quality managers in their absence

The Document Control activities take place primarily in a manufacturing environment.  Heavy lifting could be required. 

4+ years of experience in quality engineering, quality assurance, or a similar role.

Degree in quality, industrial, or mechanical engineering. 

• Role experience with a medical device manufacturer in compliance with ISO 13485 the FDA preferred.
• Excellent communication skills, both verbal and written. 
• Ability to effectively present information. 
• Strong analytical and problem-solving skills.
• Self-motivated and proactive with strong customer service orientation.
• Ability to establish and maintain effective and cooperative working relationships with those contacted in the course of work.
• Experience with data organization and presentation.
• Excellent project management skills.
• Intermediate or above skill in the use of Microsoft Office Suite required.
• Project completion driven.