Senior Quality Engineer

Position Overview

The Senior Quality Engineer is a member of the Quality team. They will work to ensure compliance with FDA and international regulations and will participate in the ongoing improvement and management of SpineFrontier’s Quality Management System. The successful candidate will work on major projects requiring in-depth knowledge and expertise.

The Senior Quality Engineer will manage junior members of the team, providing direction and mentorship while consistently demonstrating high levels of technical knowledge, ingenuity, and creativity. This position requires collaboration with the Product Development team on design and development projects as wells as collaboration with supply chain to ensure appropriate qualifications, audits, and quality controls are implemented for SpineFrontier suppliers. This is an opportunity for an experienced quality engineer to apply their knowledge and clearly see the benefits realized from their individual contribution in the ongoing improvement and management of the Quality Management System.

General responsibilities

As an integral member of the quality team the senior quality engineer will work to ensure compliance with 21 CF 820, ISO 13485, ISO 14971 during all projects and activities. This position collaborates with the engineering team on design and development helping to bring new products to market and ensures compliance throughout the product lifecycle. The QE will participate in dFMEA, aFMEA, pFMEA meetings, and requires a thorough knowledge of ISO 14971 standards and risk management principals. Additionally, the quality engineer may: 

  • Conduct PMS research and statistical analysis

  • Contribute to design verification and/or validation, as well as IQ/OQ/PQ activities 

  • Participate in the Material Review Board (MRB) and analyze NCMR trend data 

  • Perform reliability analysis and develop risk-based sampling plans  

  • Evaluate, monitor, develop, and implement standards and methods for inspection, testing, and evaluation of processes and products to meet engineering and customer requirements. 

  • Design, document and implement methods for process control, process improvement, and testing. 

  • Will assist in the CAPA process as a CAPA owner, assist in root cause analysis/investigation, and conduct risk evaluation of corrective actions as well as revision of risk documents and tables. 

  • Take ownership of risk management process and related QMS documentation 

  • Assist in FDA and ISO audits and internal audits as required 

  • Manage the quality engineering (QE) team 

  • Oversee incoming, in process and final acceptance activities 

  • Work with internal teams and suppliers to resolve Non-Conforming Material Reports 

  • Manage corrective and preventive actions within the QE team 

  • Manage the calibrated equipment program 

  • Provide quality input to product development teams 

  • Lead risk management efforts for product development teams (e.g. FMEA) 

  • Oversee verification and/or validation activities 

  • Ensure compliance with design controls throughout product lifecycle 

  • Participate in design reviews 

  • Conduct 1st party and 2nd party quality system audits 

  • Participate in the Material Review Board (MRB) 

  • Perform reliability analysis and develop risk-based sampling plans  

Required competencies

  • Must be able to read, write and communicate fluently in English. 

  • The employee in this position often communicates with employees and vendors who have inquiries, therefore must be able to read, write and communicate to exchange correct information in these situations. 

Position Requirements

To perform this job successfully, the candidate must be able to perform each essential duty satisfactorily; training will be provided as needed. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.  

Required Minimum

  •  1 to 3+ years in quality role in medical devices 

  • B.S. in engineering (Mechanical or Biomedical preferred) 

  • Strong knowledge of 21 CFR 820, ISO 13485, and ISO 14971 

  • Successful history serving as quality representative on product development teams 

  • Ability to work in an extremely fast paced and dynamic environment. 

  • Proficient in Microsoft Office Pro; Adobe, CAD (highly desirable) 

Preferred

  • · ASQ Certified Quality Engineer (CQE) 

  • ASQ Certified Quality Auditor (CQA) 

  • Experience in Orthopedic Medical Devices 

Physical Requirements

  • Position routinely requires filing, which will require opening file cabinet drawers, being able to bend for file placement.  

  • The position often needs to move objects from one place to another lifting periodically up to 15 lbs.  

  • Employee must have the visual acuity to determine the accuracy, neatness, and thoroughness of the work assigned. 

  • The employee is required to have close visual acuity to inspect products performance, analyze data and numbers, view a computer terminal;  

  • The employee is required to read extensively at a distance that is close to the eyes. 

  • The position routinely requires the employee sit for extended periods of time using a computer keyboard and monitor. 

Environmental Factors  

This position routinely uses standard computer equipment, telephones, photocopiers, filing cabinets etc. 

CAREERS


 

Join our crew! KICVentures is a private investment company founded in 2005 by Harvard-trained Dr. Kingsley R. Chin, who brings unique experience to the intersection of medicine, business and information technology. We’re equipped to identify niche healthcare opportunities and encourage total global inclusion, beginning with our team.  We’re about hands-on, heads-down efforts, complemented by a company culture that fosters engagement. Collaboration drives our innovation, and we work with the best and the brightest in the business – movers and shakers who’re all hands on deck for success. As evolution happens, we revolutionize.

 




 

How to apply

We offer tremendous room for advancement and income potential. All submissions will be held in the strictest confidence. This position is being sought after for immediate hire. The company is an Equal Opportunity Employer.

 Please no outside unsolicited recruiters

SpineFrontier