Quality Engineer in Charlottesville, VA at APEX Systems

Date Posted: 2/4/2020

Job Snapshot

Job Description

Job #:  1044918

Established Medical Device company in Charlottesville is seeking a Quality Engineer to join their team!
  • Develop and implement Risk Management File deliverables (e.g. Hazard Analysis, sFMEA, pFMEA, dFMEA, Risk Benefit Analysis report, etc.).
  • Review and monitor maintenance of Device History Files and Risk Management Files according to established procedures.
  • Lead a team through investigations, risk assessments and corrective actions of CAPAs.
  • Lead Quality System improvement projects following the DMAIC methodology and project management.
  • Lead Quality requirements within the design transfer, design control and improvement project teams.
  • Demonstrates commitment to the development, implementation and effectiveness of Quality Management System per ISO, FDA, and other regulatory agencies.
  • Support the change control process by reviewing proposed changes, performing risk assessments, and assessing the adequacy of verifications and validations.
  • Provide resolution of quality issues identified by production and project teams in accordance with established procedures.
  • Lead Quality requirements within the design transfer, design control and improvement project teams.
  • Support modification, continual improvement and maintenance of the existing Quality System
  • Perform gap assessment and Implement Corporate Policy requirements under the Quality system
  • Support the Supplier Management process ensuring proper conduct for supplier evaluation, qualification and monitoring.
  • Perform first and last article inspection as well as in process inspection based on AQL sampling.
  • Carries out duties in compliance with established business policies
  • Responsible for exhibiting professional behavior with both internal/external business associates that reflects positively on the company and is consistent with the companys policies and practices.
  • Understands and is aware of the quality consequences which may occur from the improper performance of their specific job. Has awareness of device defects that may occur in their area of responsibility, including product design, verification and validation, manufacturing and testing activities.

EDUCATION/EXPERIENCE: Bachelor's or Master's degree in Engineering or Science Field with a minimum of 6 years of related experience in Quality Engineering.
  • Experience with root cause analysis, design control, design transfer, Risk Management, and validation activities.
  • ASQ Certified Quality Engineer certification.
  • Analytical/Problem Solving Skills (e.g. DMAIC, statistical techniques, risk analysis, engineering analysis)
  • Writing and Communication Skills (e.g. write technical reports, present data analysis)
  • Interpersonal Skills
  • Service Orientation
  • Working experience of FDAs 21 CFR Part 820 Quality System Regulation, ISO 13485:2016 Medical Devices, and ISO 14971:2012 Risk Management.
  • Working experience of regulations relating to in-vitro diagnostic medical device products and software (e.g. FDAs General Principles of Software Validation and Guidance for the Content of Premarket Submission for Software Contained in Medical Devices, 21CFR Part 11, IEC 60601, IEC 62304).
  • Knowledge of regulatory submissions process.
  • Experience in Software Development Life Cycle activities and understanding of software design inputs and outputs.
  • Working knowledge of product software, analytical process software, manufacturing process software and quality system software validation methods and requirements.

EEO Employer
Apex Systems is an equal opportunity employer. We do not discriminate or allow discrimination on the basis of race, color, religion, creed, sex (including pregnancy, childbirth, breastfeeding, or related medical conditions), age, sexual orientation, gender identity, national origin, ancestry, citizenship, genetic information, registered domestic partner status, marital status, disability, status as a crime victim, protected veteran status, political affiliation, union membership, or any other characteristic protected by law. Apex will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact our Employee Services Department at 844-463-6178.