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Company description:
TeDan Surgical Innovations (TSI) designs and manufactures specialty surgical products for use in orthopedic, neuro, thoracic and spine surgeries. TSI was founded in 2006 with the goal to innovate and address evolving retraction techniques in spine surgery. We have successfully addressed the need for minimally invasive, posterior, lateral and anterior surgical approaches to the spine, and have introduced access instrumentation for neurological, orthopedic and cardiothoracic procedures. We commit to providing innovative, high-quality surgical access systems designed to optimize exposure and improve the surgeon experience.
Role Overview
The Quality Engineer II is a hands-on quality professional who supports manufacturing and post-manufacturing activities to ensure safe, effective, and compliant medical devices. This role is ideal for an engineer who enjoys solving technical problems, leading investigations, improving processes, and working cross-functionally to make measurable quality improvements. The QE II will play a visible role in driving product and process quality through failure analysis, validation support, risk-based decision-making, and data-driven continuous improvement in a fast-paced regulated environment.
Core Competencies
Apply working knowledge of ISO 13485, FDA QMSR, GMP/GDP, and Design Controls to support compliance across product and process activities.
Manage complaint investigations, CAPAs, nonconformances, and supplier corrective actions using structured root cause and risk-based methodologies.
Contribute to risk management activities in accordance with ISO 14971 to help identify, assess, and mitigate product and process risks.
Analyze manufacturing, quality, and post-production data to identify trends, performance gaps, and improvement opportunities.
Apply statistical and analytical tools such as SPC, control charts, Pareto analysis, sampling plans, and process capability analysis to monitor and improve process performance.
Lead or support root cause investigations and failure analysis for nonconformances, complaints, and product performance issues, and help implement effective corrective actions.
Develop and maintain reports, dashboards, and quality metrics that improve visibility into performance and support better decision-making.
Translate data into clear, actionable insights for Quality leadership and cross-functional stakeholders.
Review engineering, process, and supplier changes for quality impact and support validation and implementation activities.
Support process validation activities, including protocol development, execution, data analysis, and reporting, and perform measurement system analysis for inspection and test methods.
Partner with Engineering and Manufacturing to improve process capability, reduce variation, and strengthen process controls.
Support supplier quality activities through investigations, corrective actions, performance monitoring, and collaboration with internal and external partners.
Partner with Quality, Manufacturing, and Engineering to maintain process controls, inspection methods, measurement systems, and validation requirements.
Communicate technical findings clearly and work effectively across functions to resolve issues and advance improvement initiatives.
Prepare clear, concise technical documentation, including protocols, reports, procedures, and quality metrics.
Ensure traceability of complaints, CAPAs, nonconformances, supplier events, and risk management records.
Manage multiple assignments and projects effectively while balancing timelines, quality priorities, and regulatory requirements.
Demonstrate ownership, sound judgment, and follow-through in completing quality engineering activities with appropriate guidance.
Qualifications & Experience
3-5 years of Quality Engineering experience in the medical device industry, with demonstrated support for manufacturing quality and post-market activities.
Experience with complaint handling, CAPA, nonconformance investigations, supplier quality, and risk-based problem-solving.
Strong understanding of manufacturing support, failure analysis, process validation, inspection methods, measurement system analysis, and process capability.
Proficiency in quality and statistical tools (Excel required; Minitab preferred); experience with dashboards or data visualization tools is a plus.
Ability to write clear technical documentation, including protocols, reports, and procedures.
Working knowledge of Design Controls, risk management, and regulated manufacturing environments.
Strong organizational, communication, and collaboration skills with the ability to work effectively across functions.
Education
Bachelor of Science in Biomedical Engineering, Mechanical Engineering, or a related discipline.
Additional Requirements
Reasonable Accommodations
Tedan Surgical Innovations is an Equal Opportunity Employer. Reasonable accommodations may be made to enable qualified individuals with disabilities to perform the essential functions of this position.
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