Job Location
Devens, MA, USA

Position: Quality Engineer

Thank you for submitting your application and for your interest in working with us. We look forward to reviewing your profile and will get back to you shortly if there is a good fit.

Quality Engineer
Description

The Quality Engineer opportunity is a hands-on engineer position in the manufacturing facility, which offers a significant challenge for the right candidate. This position is based out of VulcanForms’ Devens, MA facility.

Responsibilities
  • Develop, communicate, and implement Quality Standards
  • Assist the Quality Engineering Manager in assuring the QMS conforms to the customer, internal, industry (i.e., AS9100, ISO 9001, ISO 13485), and regulatory/legal requirements by conducting audits and identifying gaps.
  • Monitor and analyze quality performance for VulcanForms and its sub-tiers.
  • Assure Inspecting and testing materials, equipment, processes, and products meet quality specifications.
  • Create Standard Operating Procedures and Inspection Methods
  • Collaborate to develop and implement quality and process controls and improvements
  • Conduct internal quality audits and assure corrective actions are timely and sufficient.
  • Assure that calibration methods meet customer requirements and industry standards.
  • Ensure that workflows, processes, and products comply with safety regulations.
  • Investigating and troubleshooting product or production issues
  • Lead the inspection of manufactured parts, issue non-conformance reports, and facilitate the disposition of MRB hardware and corrective action tasks.
Requirements:
  • A degree in engineering or a related field is required.
  • Five years of experience in Quality Assurance/Quality Control
  • Expert knowledge of IS0 9001:2015 Quality Management System
  • Experience working with Medical Device Quality (ISO 13485:2016 and 21CFR 820s) or Aviation Quality AS9100
  • Knowledge of GMP, FDA QSR, and MedAccred requirements.
  • Ability to lead and educate a diverse team of technologists
  • Root Cause Analysis, Data analysis, and Statistical Process Control.
  • Skilled using MS Office
  • Strong organizational, analytical, problem-solving, and management skills
Preferred Experience:
  • Cognizant of Quality trends and international regulatory compliance standards, including MDD 93/42/EEC, ISO 13485, and other applicable global requirements.
  • Experience in aerospace, defense, or medical devices manufacturing
  • Experience working in ITAR/EAR compliant organization
  • Experience with Metal Laser Powder Bed Fusion.
  • Project management experience
  • Quality control certification (ASQC etc.)