Born out of MIT, VulcanForms is commercializing the first fully scalable industrial metal additive manufacturing (AM) solution. Building the world’s most powerful and advanced metal AM system is the first step towards our vision of lights-out, highest quality metal AM mass production. We are a team of leading technology and operational experts with decades of experience in advanced manufacturing, materials, automation, and robotics. We are continuously seeking contributors who demonstrate outstanding integrity, intelligence, hunger, accountability, and a passion for learning.
Job Description
The Quality Engineer position is a hands-on engineer role in the manufacturing facility located in Devens, Massachusetts. This position offers a significant challenge for the right candidate.
- 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 assures 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.
- US Citizen, lawful permanent resident of the US (or green card holder). VulcanForms is an ITAR facility
- BS degree in engineering or a related field is required
- 7+ years of experience Part Layouts and Drawing Interpretation Expertise
- First Article and inspection method sheet creation
- Sampling Plan Expertise
- Ability to complete simple calibrations
- The knowledge base to set up and establish an inspection area
- Ability to run CMMs and Visual Inspection Devices
- 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
- 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 device manufacturing.
- Experience working in ITAR/EAR compliant organization
- Experience with Metal Laser Powder Bed Fusion.
- Project management experience
- CMM programming
- Quality control certification (ASQC etc.)