Devens, MA, USA
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.
- 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.
- 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
- 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.)