Medical Product Quality Engineer
VulcanForms builds and operates advanced digital infrastructure enabling the world's critical industries to innovate, grow, and deliver sustainable impact. Founded in 2015, VulcanForms invented and commercialized the world's first industrially scalable laser metal additive manufacturing (AM) solution and pioneered integrated digital production systems. We are a team of leading technology and operational experts with decades of experience in advanced manufacturing, materials, automation, and robotics. We continuously seek contributors who demonstrate outstanding integrity, intelligence, accountability, and a passion for learning. We celebrate diversity and are committed to creating an inclusive environment for all employees.
VulcanForms Inc. seeks a Medical Product Quality Engineer for our Devens, MA location.
As the Medical Product Quality Engineer at VulcanForms Inc., Devens, MA, you will be a hands-on engineer involving metal additively manufactured parts. VulcanForms Inc. is a manufacturer of complex, high value engineered components in serial production at the world's most powerful additive foundry. This position offers a significant challenge for the right candidate.
- Lead the FDA medical product development for the Quality Management System.
- Ensure the IQ, OQ, and PQ process meets customer expectations and is integral to VulcanForms Quality Management System.
- Develop, communicate, and implement Quality Standards
- Assist the Quality Engineering Manager in assuring the QMS conforms to the customer, internal, industry (i.e ISO 13485), and regulatory/legal requirements by conducting audits and identifying gaps.
- Assure Inspecting and testing materials, equipment, processes, and products meet quality specifications.
- Collaborate to develop and implement quality and process controls and improvements.
- Assure that calibration methods meet customer requirements and industry standards.
- 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.
- Expert knowledge of medical product quality management qualification systems
- Experience in project management of the IQ, OQ, and PQ process
- 7+ years of experience in medical product development and Quality System creation
- 7+ years of experience in Quality Assurance/Quality Control
- First Article and inspection method creation
- Ability to complete coordinate calibration systems
- Expert knowledge of IS0 9001:2015 Quality Management System
- 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
- Strong organizational, analytical, problem-solving, and task-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
- Experience in statistical analysis programs
- Sampling Plan Expertise
- Create Standard Operating Procedures and Inspection Methods
- Proficient in MS Office Suite (Outlook, Word, Excel, PowerPoint)
- Strong sense of ownership
- Team player with excellent communication skills
- Excited about taking on new challenges in the metal additive manufacturing industry and working in a fast-paced startup environment
- Self-motivated, hands-on, with a practical mindset, and capable of setting and reaching ambitious goals
- Medical, dental, vision, and life insurance are available to you starting on your first day of employment
- Generous time off package, including vacation PTO, sick PTO, and company-paid federal holidays
- 401(k) with company match and stock options