Quality Engineer

FX Shoulder Solutions is a specialized provider of shoulder arthroplasty implants, offering a comprehensive range of solutions for degenerative and trauma-related cases. As the only company dedicated exclusively to this field, we deliver tailored products for our medical partners. With a global headquarters in Viriat, France, and a U.S. headquarters located in Dallas, Texas, we value strong, personalized relationships with our distributors, representatives, surgeons, and medical professionals.

Our team emphasizes customer-focused service and support to enhance patient care and outcomes.

The overall goal of the Quality Engineer is to ensure that FX Shoulder Solutions is compliant with federal regulations and industry standards including, but not limited to, 21 CFR 820, EU-MDR, and ISO 13485. This includes managing the quality system processes like document control, training, change control, complaints, and CAPA and reporting their metrics to top management. It also includes working on assigned projects, including R&D projects and process improvement projects.

This position interacts with all other departments at both sites and supports multiple projects  Quality Engineer reports to the VP of QARA and needs to have a full understanding of the corporate quality management system (QMS) and its KPIs and objectives.

• Manage the US side of Document Control, Document Changes, Training, Internal Audits, Supplier Management, Complaint Handling, and Calibration.
• Work with the QA team in Viriat to ensure the proper division of work between the sites.
• Review requests for modifications to controlled documents, assist with the impact assessment of the requested modifications, assist with the implementation of the approved changes, and ensure compliance with internal procedures.
• Assist with training users to the new and revised procedures and work instructions.
• Manage the control of external document libraries.
• Assist with the planning, execution, and documentation of internal and supplier audits.
• Participate as the QA team member in the Change Control, Product Development, CAPA, and Risk Management processes.
• Develop and oversee adherence to Good Documentation Practices in the US.
• Manage US Calibrations and Supplier Monitoring and maintain the schedules / tracking.
• Propose and help implement QMS process improvements based on feedback from users.
• Other assigned responsibilities upon request

• Bachelor's degree in engineering (biomedical, mechanical, or similar).
• Minimum 3 years of experience in the medical device industry, orthopedic devices preferred.
• Experience with Medical Device Quality Management Systems.
• Working knowledge of and experience with 21 CFR 820, EU-MDR, and ISO 13485 requirements.
• Experience working in and managing cross-functional project teams.
• Proficiency with Microsoft Office (Word, Excel, PowerPoint, Outlook, SharePoint, Teams).
• Able to work independently and in a team environment.
• This is a full-time onsite position

• Strong analytical and problem-solving skills.
• Demonstrated accuracy and attention to detail.
• Demonstrated ability to communicate effectively with others.

• Able to adapt in a quickly changing environment.
• Interested in new challenges and able to learn quickly.
• Motivated and professional.
• Produce high quality work at a fast pace