Quality Engineer

What You Will Do at Spinal Simplicity!

• 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.

• Regularly required to work within an office environment, with extended periods of time spent working on a computer.
• Required to operate office equipment (phone and computer) and operate manufacturing/sterilization/inspection equipment.
• Operate equipment and gauges to evaluate quality measures and standards for products and equipment.
• Occasionally lift and/or move 50+ pounds – medical devices, trays and related equipment.

• 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 (ISO
  14971).
• 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…