Join the SpineFrontier Team as Quality Engineer

Join the SpineFrontier Team as Quality Engineer
Join the SpineFrontier Team as Quality Engineer

17 April, 2018

Position Overview

This position requires an Engineering Degree and 0-2 years of the relevant industry experience. The Quality Engineer will work as a member of the Quality team 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 serve as the quality representative on product development teams, facilitate compliance efforts across the organization, oversee acceptance activities, participate in complaint handling, and implement corrective/preventive action. This role is also highly integrated with supply chain management to ensure appropriate qualifications, audits and quality planning throughout the supply chain. This is an opportunity for an experienced quality engineer to apply their knowledge and clearly see the benefits realized from their individual contribution.

Duties and responsibilities

Core duties and responsibilities include the following. Other duties may be assigned.
  • Lead risk management and V V efforts for product development teams, including the facilitation of FMEA team meetings
  • Ensure adherence to defined design and development procedures throughout the product life-cycle
  • Manage the Engineering Change Order Process
  • Provide quality and possibly regulatory input to product development teams (i.e. ECOs, rationales, CAPAs, etc.)
  • Conduct engineering evaluations and root cause analyses
  • Work with internal teams to resolve the disposition of non-conforming material
  • Implement corrective and preventive actions throughout the organization
  • Participate in MRB and Design Review meetings
  • Participate in internal and external quality system audits
  • Identify opportunities for continuous QMS improvement, and enact changes as applicable
  • Lead risk management efforts for the product development teams
  • Manage verification and /or validation activities
  • Ensure compliance with design controls throughout the product life-cycle
  • Manage incoming, in process, and final acceptance activities
  • Conduct internal and supplier quality system audits
  • Conduct investigations and documenting assigned complaints
  • Facilitate corrective and preventive actions throughout the organization
  • Participate in Material Review Board and Design Reviews
  • Own and manage Quality training assuring on-going compliance with regulations
  • Work with internal teams and vendors to resolve disposition of Non-Conforming Material

Qualifications

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, or to train technically-competent individuals in company specific software.

Our Perfect Candidate

Education and Experience

 

  • Bachelor’s Degree in Engineering (Medical or Biomedical preferred)
  • 0-2 years’ experience in quality (required) or regulatory (desirable) role in medical devices
  • Strong Knowledge of the 21CFR 820 QSR, ISO 13485:2003, MDD, ISO 14971, and global harmonization
  • Successful history serving as a quality representative on product development teams
  • Legally authorized to work in the United States on a regular full-time basis without restrictions
  • Experience in Orthopedic Medical Devices
  • Quality auditing experience (preferred: in lead role)
Required Abilities and Skills
  • Excellent verbal and written communications skills
  • Ability to work in an extremely fast paced and dynamic environment
  • Problem-solving and critical-thinking skills
  • Proficiency in Microsoft Office Applications including Excel, PowerPoint, and Word
  • Proficiency in Microsoft Office Pro; Adobe, AutoCAD, and SolidWorks
Company offers
  • Annual salary is commensurate with experience and education
  • Comprehensive benefits package available including: Healthcare Insurance, Paid Vacation Holidays, 401k, Bonuses, Merit Increases, Employee Pool (stock) Plan and Growth Opportunities

Working conditions

Work is generally performed within an office environment, with standard office equipment available. Travel up to 10%.

Physical requirements

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

Location

Malden, MA

Apply Now

SpineFrontier

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