Director of Quality Systems (Medical)
Director of Quality Systems
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 Director of Quality Systems for our Devens, MA, location.
VulcanForms is seeking a Director of Quality Systems that is an experienced expert in operating in facilities that are ISO certified. The Director of Quality Systems will lead the quality team in developing and executing Quality operations in-line with VulcanForms' mission and vision. The Director will implement and monitor all company quality systems to demonstrate compliance with all regulatory requirements, including ISO 13485. This position is responsible for providing quality guidance for design, development, and manufacturing strategies related to the production of parts for multiple industries, including medical.
The Director of Quality Systems must have knowledge of quality systems and compliance to support systems, software, and service. This position is accountable for ensuring the Quality Management System (QMS) is defined and executed to meet all supplier management, manufacturing, new product development, quality control testing, manufacturing, and shipping activities. QMS compliance will be met by ensuring that activities previously noted are conducted according to prescribed procedures, policies, and regulations. The role will also be responsible to lead, manage, and coach the Quality team.
- Evaluate production operations from a strategic level to ensure that products meet quality, integrity, functionality, and other specifications and requirements. Develop, implement and maintain quality management systems, policies, procedures and standards in compliance with regulatory requirements such as ISO 13485 and FDA regulations for medical devices.
- Lead the development and implementation of quality control processes and procedures for metal 3D printing medical devices.
- Develop and implement a comprehensive audit program to assess compliance with quality systems regulations and standards.
- Collaborate with cross-functional teams to ensure product quality, regulatory compliance and timely resolution of quality issues.
- Develop and implement training programs to ensure that employees understand quality requirements and procedures.
- Identify opportunities for continuous improvement in quality systems and processes.
- Manage and mentor the quality team to ensure their continued growth and development.
- Develop an internal audit program that meets applicable sections of ISO and FDA regulations in all facilities.
- Manage the specifications and forms on the company intranet site.
- Review quality control documentation such as checklists, logs, and reports for effectiveness, accuracy, and relevance.
- Conduct random inspections and quality control checks.
- Assure that KPIs are in place, measured, and successful.
- Update and create additional reports and post the results in both facilities.
- Performs other related duties as assigned.
- At least 10 years of experience in quality management, preferably in a medical device or regulated industry.
- Strong knowledge of quality management systems, regulations and standards, including ISO 13485 and FDA regulations.
- Experience leading cross-functional teams to achieve quality goals.
- Excellent communication, interpersonal and leadership skills.
- Experience with risk management and validation processes for medical devices.
- Experience working with regulatory bodies such as the FDA, notified bodies and health authorities.
- Six Sigma or Lean Manufacturing certification.
- 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