Quality Engineer
Stereotaxis - St. Louis, MO

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Job Description
This position is responsible for helping to ensure compliance with the US and International Quality System requirements. Areas of focus are product development/design controls, supplier quality and failure investigation. This position is located at the St. Louis, MO facility.

-Assist with root cause failure investigations related to finished product complaints.
-Act as Quality Engineering representative on development teams to ensure compliance with FDA and internal (Stereotaxis) design control system requirements
-Develop and maintain quality documents.
-Support risk analysis activities (i.e., risk mgmt planning, FMEAs, Hazard Analysis) as required to support product development activities.
-Perform DHR review/release of sterile/non-sterile products.
-Coordinate the reporting and analysis of quality data and resolution of material and product quality issues.
-Manage suppliers on an ongoing basis via regular contact, periodic audits and other methods to guarantee consistent high quality performance on an ongoing basis.
-Carry out Vendor Approval/Surveillance audits to ensure that suppliers are capable of meeting Stereotaxis quality requirements on a continuous basis.
-Lead or participate on cross functional Quality Improvement Teams with Suppliers.
-Support site quality system activities to ensure compliance with FDA, QSR, and ISO 13485 requirements.
-Support in validation of various types of equipment, processes and test methods (IQ/OQ/PQ) as required.
-Perform internal audits as needed.
-Perform corrective and preventive action activities and verification of corrective action.

Job Requirements
-Experience with electronic quality system documentation management preferred.
-Excellent written and verbal communication skills.
-Willingness and ability to work in a team environment and to be an effective Product Development Team member.

-Bachelor’s degree in a Technical field from a college or university highly preferred.
-Minimum of 3 years of related Quality Assurance experience in a medical device design and/or manufacturing facility highly preferred.
-Strong knowledge of US and International Quality System regulations related to design control, risk analysis, and GMPs highly preferred.
-ASQ Certified Quality Engineer certification and/or ASQ Certified quality Auditor is preferred.