Quality Engineer

3 weeks ago

St Louis, United States Stereotaxis Full time

Shift Type

Job Title

Quality Engineer

Education

Bachelor's Degree

Location

Stereotaxis - St. Louis, MO 63101 US (Primary)

Career Level

Entry Level

Category

Regulatory and Compliance

Date Needed By

Job Type

Full-time

Travel

Job Description

Company Description:
Stereotaxis is the global leader in innovative robotic technologies designed to enhance the treatment of arrhythmias and perform endovascular procedures. Its mission is the discovery, development and delivery of robotic systems, instruments, and information solutions for the interventional laboratory. These innovations help physicians provide unsurpassed patient care with robotic precision and safety, improved lab efficiency and productivity, and enhanced integration of procedural information. Core components of Stereotaxis' systems have received regulatory clearance in the United States, European Union, China, Japan, Canada, and elsewhere. For more information, please visit www.stereotaxis.com.
Position Summary:
The Quality Engineer I is responsible for ensuring compliance with the US and International Quality System requirements. Areas of focus are product development/design controls, process improvement, supplier quality, and failure investigation.
Essential Responsibilities:
•Act as Quality Engineering representative on development teams to ensure compliance with Regulations, International Standards, and internal design control system requirements.
•Assist with complaint handling processes, nonconformance/deviation processes, and perform corrective and preventive action activities.
•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 and non-sterile products.
•Coordinate the reporting/analysis of quality data and resolution of material and product quality issues
•Improve product quality by making recommendations for change while working with relevant teams and departments to improve products
•Ensure products adhere to company and industry quality standards
•Drive continuous improvements in all areas, focusing on key performance indicators
Support site quality system activities to ensure compliance with international Regulations and Standards, including but not limited to 21 CFR 820, ISO 13485, EU MDR, and MDSAP requirements
•Conduct internal audits, including closing out audit findings, create audit finding reports and determine proper corrective and preventative actions.

Job Requirements

Qualifications & Skills:
•B.S. Degree in a Science or Engineering field highly preferred and/ or business experience.
•1-3 years' experience in regulated medical device industry highly preferred.
•Strong knowledge of global Quality System regulations related to design control, risk analysis, and GMPs preferred.
•Professional certification(s) relevant to the position preferred (e.g., CQA, CQM, and/or CQE) highly preferred.
•Experience with electronic quality system documentation management highly preferred.
•Excellent written and verbal communication skills.
•Legally authorized to work in the United States.
Work Conditions:
This role is an in-office position at Stereotaxis' headquarters.
Culture:
Stereotaxis values steadfast integrity, intellectual excellence, responsiveness and reliability, and a dedication to constant improvement. We take pride in the positive impact of our work and in building a collaborative and innovative work environment that embraces challenge.

Hiring Manager

Exemption Type

# of Hires Needed

1

Wage Amount

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