Spinal Simplicity · 5 hours ago
Quality Engineer
Overland Park, KS
Full-time
Onsite
Entry, Mid Level
2+ years expSpinal Simplicity is a company dedicated to the creation of innovative simple solutions for complex spinal problems. They are seeking a Quality Engineer to contribute to the company’s Quality Management System by monitoring products and processes, identifying defects, and developing corrective actions to ensure compliance with regulatory requirements.
Health CareManufacturingMedical DevicePharmaceutical
Hiring Manager
Heather Bledsoe
Responsibilities
Assure technical regulation and standards’ requirements as defined by engineering technical specification / drawings are met
Implementing methods to inspect, test and evaluate the reliability of manufacturing processes, products and production equipment
Preparing reports by collecting, analyzing and summarizing data
Assure design processes are conducted in compliance with the Corporate Quality Plan including the company’s Risk Management Procedure and ensure validation and testing protocols are robust. Instill an emphasis on designing and testing for reliability within the manufacturing and development activities. Ensure FDA, ISO, and other regulatory requirements are met
Review and assess manufacturing processes follow applicable design and regulatory requirements to result in acceptable product at every stage of manufacturing
Work with contract manufacturers and suppliers to improve quality through qualification and surveillance audits, production document review, implementation of engineering changes and other procedures
Act as a liaison between management, engineering, and contractors/suppliers on quality issues
Perform corrective and preventive actions for nonconformance and complaints:
Identify and work with Engineering, Operations, and other departments as a cross-functional team
Adequately define the discrepancy and why it is not conforming
Provide containment of suspect material and interim actions to prevent quality spills
Direct the investigation to assure all information available is collected, information is correct/factual and adequate to establish point-of-cause
Use accepted RCA techniques to determine root cause (5-Why?, 3-Legged 5-Why?, Ishikawa, etc.)
Work with the cross-functional team to develop robust corrective, preventive, and lateral actions
Verify actions are effective
Supporting regulatory compliance with ISO 13485, applicable FDA, MDD/MDR and CMDR regulations, and other applicable national/international regulations
Contribute as a subject matter expert during medical device regulatory audits and inspections, as well as conduct internal quality audits, supplier quality audits, and due diligence audits. Suggest appropriate actions on reports and recommendations provided by authorized agencies, consultants, etc
Working in accordance with deadlines for delivery of products
Perform other relevant duties, as assigned
Qualification
Required
Bachelor's degree in quality, industrial, manufacturing, or mechanical engineering, or
2+ years of experience in quality engineering, quality assurance, or
Experience in quality engineering and professional certification (e.g., ASQ CQE)
Experience authoring and maintaining FMEA, PPAP, and process work plans
Ability to read, analyze, and interpret drawings (including ASME Y14.5 GD&T), technical procedures, and government regulations
Relevant knowledge and proficiency with medical device regulation (e.g., FDA QMSR, ISO 13485 Quality System Standards, EU MDR 2017/745 and related international standards) and risk management (ISO14971)
Possess requisite knowledge and expertise in the spine and orthopedic products of the Company. Ability to communicate medical product knowledge, as well as clinical knowledge related to spinal and/or relevant orthopedic anatomy, spinal and relevant orthopedic surgical procedures and techniques
This position requires driving a personal vehicle or a rented vehicle on behalf of the company; therefore, all Company team members must successfully complete a motor vehicle history check, possess and maintain a current, valid driver's license in their state of residence
Ability to write reports, project proposals, and procedures
Solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists. Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form. Analytical and problem-solving skills. Able to define problems, collect data, establish facts, and draw valid conclusions
Ability to work effectively in a team environment
Excellent Communication skills, verbal and written, along with strong public speaking skills
Ability to travel overnight and for extended periods of time
Company
Spinal Simplicity
Spinal Simplicity is a medical device company that develops minimally invasive spinal technologies for complex spinal problems.
11-50 employees
Funding
Current Stage
Late StageTotal Funding
$44.54M2024-12-26Series Unknown· $6.1M
2022-06-21Series D· $5M
2021-08-20Series D· $10M
Leadership Team
Tim McCown
Chief Operating Officer
Recent News
Company data provided by crunchbase