Staff Product Quality Engineer

Location: Devens, MA

Department: Quality

Job Purpose

The Staff Product Quality Engineer plays a hands-on role in driving product quality and regulatory compliance throughout the development and production of advanced metal additive manufactured components. This role is critical in building scalable, quality-focused processes that enable efficient production of high-performance parts, from prototyping through full-scale production. Working cross-functionally with R&D, Manufacturing, Operations, suppliers and customers, the Staff Product Quality Engineer will lead quality initiatives, process validations, and continuous improvement efforts, ensuring that products meet rigorous quality, reliability and regulatory standards.

Key Responsibilities

• Partner closely with R&D, Manufacturing and Operations to integrate quality controls from design through manufacturing, ensuring product designs are manufacturable at scale with minimal defects and meet customer and regulatory requirements.
• Serve as a core Quality team member during new product development and introduction activities, with focus on metrology and metallurgical testing.
• Provide hands-on support to manufacturing lines, driving root cause investigations and implementing effective corrective and preventive actions to resolve product and process quality issues.
• Promote awareness of Quality and Regulatory requirements across teams to ensure compliance with internal Quality Management System standards and external regulations (e.g., ASTM standards for Ti-6Al-4V).
• Set up and validate metrology inspection methods and mechanical/metallurgical testing protocols, including operator training.
• Develop and implement Statistical Process Control (SPC) and lead validation/verification of new and existing products and processes.
• Develop and maintain key quality system documentation including Design History Files (DHF), Device Master Records (DMR), Device History Records (DHR), change orders, and Master Validation Plans.
• Serve as a Material Review Board team member to evaluate and disposition of non-conformances.
• Investigate escalated product complaints to root cause and drive timely resolution.
• Monitor product and process performance metrics and act upon trends to drive continuous improvement to improve product quality and operational efficiency.
• Support supplier quality activities, including qualification audits, as a subject matter expert and ensure supplier materials meet quality criteria.
• Collaborate with suppliers and customers to address and resolve quality issues.
• Develop and implement quality control strategies for Ti-6Al-4V additive manufacturing processes; Establish and validate metallurgical test equipment for titanium alloys (e.g., Ti-6Al-4V), including tensile, hardness, density, and microstructure evaluations.
• Lead quality engineering projects, working across manufacturing engineering, operations quality control, metallurgical lab, and NPI teams, to develop and implement quality process controls to ensure compliance with AS9100, ISO 9001, and ISO 13485 standards.

Qualifications

• Bachelor’s degree in Engineering, Mechanical Engineering, Materials Science, Quality, or related field preferred; equivalent hands-on experience will also be considered.
• 6+ years of quality engineering experience, ideally in advanced manufacturing or additive manufacturing environments.
• Strong knowledge of quality system standards and regulatory compliance, including GMP, FDA QSR, and ISO 13485.
• Proven experience with process validation, root cause analysis, data analysis, statistical process control (SPC), and corrective action implementation.
• Hands-on experience with titanium alloys (e.g., Ti-6Al-4V) additive manufacturing processes is a strong plus.
• Strong organizational, analytical, and problem-solving skills in a manufacturing environment.
• Proficiency in metrology techniques and mechanical/metallurgical testing methods.
• Demonstrated ability to lead cross-functional projects, influence stakeholders, and drive quality initiatives from concept through production.
• Excellent communication skills with experience interfacing with suppliers and customers. 
• Lean, Six Sigma, or similar continuous improvement certification is a plus.

VulcanForms offers a competitive salary and equity package. Actual compensation is based on factors such as the candidate's skills, qualifications, and experience. In addition, VulcanForms provides comprehensive benefits including medical, dental, vision, and life insurance; generous paid time off; and a 401(k) plan with company match. 

The annual base salary range for this position is $117,477-$161,531.

About the Company

About us
Founded in 2015 to develop the world’s first industrially scalable laser metal additive manufacturing solution, VulcanForms is reshaping how the world manufactures critical products. We build and operate advanced digital infrastructure that enables innovation, accelerates growth, and supports sustainability across aerospace, defense, medical, and other essential industries. Through our vertically integrated capabilities, including scalable additive manufacturing and precision machining, we deliver true end-to-end production at scale by combining cutting-edge technology with a foundation of proven industrial craftsmanship. Our team brings deep expertise in manufacturing, materials science, software, automation, and operations, united by a shared commitment to quality, curiosity, and accountability. We foster an inclusive culture where people take ownership, solve meaningful problems, and continuously learn, because we believe diverse perspectives lead to better outcomes.