Quality Engineer (Sr/Staff Level)

About Tenon Medical:

Tenon Medical is a Medical Device company dedicated to delivering innovative surgical solutions for patients suffering from sacroiliac joint (SIJ) disorders that fail conservative care. Our flagship technology, the Catamaran SI Joint Fusion System, offers a minimally invasive surgical solution that places a single, titanium implant directly into the SI joint, transfixing it along its longitudinal axis. In addition to this, we have also received FDA 510(k) clearance for our SImmetry SI Joint Fusion System and continue to expand our portfolio with a strong pipeline of next-generation products in development. Come join our experienced leadership team and help advance our mission to improve the lives of patients with chronic SI joint pain.

Position Description:

The Quality Engineer position will oversee all incoming and in-process quality inspections. You will oversee the maintenance of quality records following existing Standard Operating Procedures and create new SOP’s and will drive continuous improvement and efficiency while also maintaining our quality standards.

Essential Duties and Responsibilities:

• Coordinate ongoing external parts testing with third-party partners, including first article inspections for new products
• Develop detailed and dynamic tracking tools to monitor test results and identify part-specific drift potential
• Manage incoming, in-process, packaging, labeling, and engineering development inspections
• Ensure compliance with FDA Quality System Regulations (QSR) and applicable ISO requirements for inspection-related activities
• Use your knowledge of Quality Systems to formulate and carry out company directives
• Effectively collaborate with cross functional peers, ensuring alignment on key quality issues
• Allocate team members and material resources as needed
• Interface with the FDA, State agencies, and notified bodies during routine ISO audits and FDA inspections, with support from the Director of RA/QA
• Ensure adherence to health and safety guidelines
• Perform other duties as assigned

Key Competencies:

• Experience in statistical and data analysis
• Strong understanding of FDA QSRs, ISO standards, and the Medical Device Directive (MDD)
• Knowledge of sterilization requirements for medical devices
• Proficiency with technical writing of protocols, analytical reports, ECOs, SOPs, Work Instructions, and Inspection Methods
• Practical knowledge in Statistical Process Control (SPC), Process Capability, Gage R&R, DOE, software Quality Assurance, electronic records, and risk analysis
• Intermediate to advanced computer skills, such as Microsoft Office applications including Word and Excel

Qualifications:

• B.S. degree with of 10 years of experience in quality assurance and/or engineering within the medical device industry; an equivalent combination of education and industry experience will be considered
• ASQ certifications such as CQE, CQA, CQM, or equivalent preferred
• Experience in a small company environment