Medical Device Software Quality Engineer

4 weeks ago

Devens, United States VulcanForms Inc. Full time

About 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 Medical Device Software Quality Engineer for our Devens, MA location.

Job Purpose

As the Medical Device Software Quality Engineer at VulcanForms Inc., Devens, MA, you will be the subject matter expert of regulatory compliance requirements for verification, validation, and maintenance processes of non-product software. This key member of the Quality Engineering department will be responsible for validation strategies and improving quality processes for non-product software systems and applications used throughout the organization.

Key Accountabilities

  • Responsible for developing, executing, and maintaining computer system validation for applicable software programs which are used as execution of quality management system processes or critical business functions, in accordance with current applicable standards and regulations (including FDA 21 CFR Part 11, FDA General Principles of Software Validation and ISO 13485)
  • Manage and maintain non-product software validation processes which blend industry best practices and the needs of the company to ensure accurate and reliable performance of non-product software in accordance with the intended use of the software within the organization and current regulations
  • Develop, execute, and maintain the site software validation master plans.
  • Work with the digital systems team to develop software requirements specifications, software design specifications, software validation protocols, and software validation reports.
  • Provide guidance and serve as the quality team representative for software development lifecycle and software changes.
  • Maintain a company-wide computer system inventory, working with IT and system owners to establish and maintain necessary GxP assessments
  • Maintain effective communication with cross-functional project teams on scope, requirements and intended use changes
  • Participate with software owners and IT in the software vendor selection process
  • Participate in internal and external audits as the subject matter expert in non-product software
  • Monitor and audit the non-product software quality processes for compliance, effectiveness, continued alignment with applicable regulatory and statutory requirements and opportunities for process improvements
  • Assure the QMS conforms to the customer, internal, industry (i.e., AS9100, ISO 9001, ISO 13485), and regulatory/legal requirements.
Qualifications
  • Minimum of 7 years of experience in software quality in the medical device industry
  • Knowledge of GMP, FDA QSR, ISO 13485, FDA 21 CFR Part 11, and FDA General Principles of Software Validation
  • 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

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