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 Chief Quality Officer for our Devens, MA, location.

Job Purpose

VulcanForms is seeking a Chief Quality Officer, an experienced executive leader within the Medical Device manufacturing industry. This position reports directly to the CEO and will oversee all VulcanForms facilities to drive quality management strategies and activities, culminating in the highest level of product quality and compliance. The Vice President of Quality will design, implement, and lead continuous quality improvement efforts for all VulcanForms facilities, implementing and coordinating programs, procedures, and initiatives that meet all regulatory requirements, including but not limited to ISO 13485, IQ/OQ/PQ, and FDA regulatory requirements.

This executive-level position provides thought leadership across the organization to guarantee compliance with all elements of VulcanForms QMS. The leader will ensure quality performance is measured, consistently reported, and escalated to all executive management. This individual will be responsible for the development and tracking of Quality KPIs, metrics, budget, and other performance indicators. This individual will lead all current and future Quality responsibilities for the organization.

The Chief Quality Officer must be an expert and respected thought leader in the medical device industry's quality systems, processes, support, compliance, and regulatory affairs. You will be accountable for leading and coaching the Quality team and ensuring all functions of VulcanForms are operating according to defined procedures, policies, and regulations. The successful candidate will be able to collaborate and work closely with various teams and functions, including manufacturing, supply chain, finance, facilities, and process development, to ensure GMP standards and compliance with global regulations and support regulatory filings and audits.

Key Accountabilities

• The VulcanForms ISO 13485 certification team's leadership includes managing and maintaining our QMS and coordinating relevant training for all staff.
• Serve as the leader of our Medical Device Center of Excellence (COE) and be a focal point for sales and marketing and "best practices" associated with medical device development.
• Assure that manufacturing quality and performance data are comprehensively measured, trended, reported, and acted on promptly to ensure compliance and support continuous improvement.
• Facilitate the continued expansion of our verification capabilities for hardware and software through organic growth and 3rd party partnerships.
• Create a culture of continuous learning across areas of responsibility by identifying the root causes of quality issues, and organizational learning is institutionalized.
• Drive the mission-driven culture of the organization using knowledge to connect the importance of what we are doing to patients' lives to employees' daily activities.
• Develop and execute a strategy to continue to evolve and elevate our Regulatory experience to provide additional value to our Medical Device clients.
• Keep VulcanForms one step ahead of emerging regulatory requirements such as Cybersecurity, IEC – 60601 updates, FDA guidance documents, etc.
• Interact with our clients through meetings, presentations, design reviews, and informal interactions - building trust and respect through a highly collaborative development process.
• Be a visible thought leader representing VulcanForms Medical Device Development expertise via speaking engagements, blogs, committee participation, trade shows, etc.
• Have fun doing extraordinary work with amazing people and helping us support and grow our culture.

Qualifications

• 10+ years of experience leading a Quality team in the Medical Device industry.
• Experience leading teams that execute projects under ISO 9000, ISO 9001, ISO 14971, FDA 21 CFR 820.30, ISO 13485, IEC 62366, etc.
• Experience leading teams that are developing software per IEC 62304 and have experience in the creation and execution of software verification and validation protocols and reports.
• Experience developing regulatory submission support documentation in the form of comprehensive Design History Files.

Preferred

• Experience working at organizations of various sizes (startups to Fortune 500).
• Customer-centric attitude and personality.
• Entrepreneurial and growth mindset.
• Balance the need for policy rigor and discipline with a pragmatic sense of efficiency and effectiveness in real-world, day-to-day operations.
• Highly motivated, a self-starter, and can manage multiple priorities.

Benefits

• Fully paid medical, dental, vision, and life insurance are available starting your first day.
• Generous time-off package, including PTO, sick time, and company-paid holidays.
• 401(k) with company match
• Stock Options