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SalaryAbout us
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 Senior Medical Device Quality Engineer for our Devens, MA location.
Job Purpose
As theSenior Medical DeviceQuality Engineerat VulcanForms Inc., Devens, MA, you will be a hands-on engineer in a role 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.
Key Accountabilities
- Provide Quality Engineering support to ensure compliance with the Quality System regulatory requirements and the business strategy of the company
- Represents Quality as a team member to support new product development/introduction activities
- Supports the manufacturing line to address quality issues and resolution. Investigate and troubleshoot product or production issues.
- Promotes awareness of Quality and Regulatory requirements
- Leads or participates in the development of process and procedure development/changes
- Develops process control methods and, as applicable, applies statistical process control (SPC) methods to evaluate current processes and process changes
- Supports validation and verification strategy for new and existing products and processes as assigned
- Leads the development and maintenance of Master Validation Plans
- Participates in the CAPA process as required as an assignee or project team member
- Investigates escalated product complaints to root cause to ensure timely customer response and correction
- Monitors product and process performance metrics and acts upon trends (positive or negative)
- Serves as MRB team member to ensure proper disposition of non-conformances
- Authors, reviews, and approves Quality System documentation including change orders, DHF documents, DMRs, and DHRs
- Support supplier quality team as needed as an SME in supplier qualification audits
- Interfaces with suppliers and customers to resolve Quality issues
- Develops sampling plans
- Develops and drives measurable Quality improvements relating to products and processes
- Ensure Inspecting and Testing of materials, equipment, processes, and products to meet quality specifications.
- Create test and inspection method and develop and execute test method validations
- Collaborate to develop and implement quality and process controls and improvements.
- Assure the QMS conforms to the customer, internal, industry (i.e., AS9100, ISO 9001, ISO 13485), and regulatory/legal requirements.
Qualifications
- Minimum of five years of experience in quality in the Medical Device industry
- Knowledge of GMP, FDA QSR, and ISO 13485 requirements
- Knowledge of Root Cause Analysis, Data analysis, and Statistical Process Control concepts
- Strong organizational, analytical, and problem-solving skills
- 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, agile, hands-on, with a practical mindset
Benefits
- 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 14 company-paid federal holidays
- 401(k) with company match and stock options
