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.
ESSENTIAL JOB RESPONSIBILITIES:
-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
-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
-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.
SKILLS AND ABILITIES:
-Experience with electronic quality system documentation
-Excellent written and verbal communication skills.
-Willingness and ability to work in a team environment
and to be an effective Product Development Team member.
EDUCATION AND EXPERIENCE:
-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.