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Sarasota, FL 34234 US
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
- Oversees all customer returns (OOBF, Warranty, Complaints, etc.)
- Failure Analysis of Returns
- Quality Team Lead
- Quality Subject Matter Expert for all Quality areas
- 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.