Senior NPI Quality Engineer: Advanced Manufacturing & Equity

VulcanForms Inc.; Harvard (MA); On-site; USD 117,000 - 162,000; Full time

Benefits offered by this job

Medical Insurance

401(k) matching

Equity package

Job summary

VulcanForms Inc. is seeking a Staff NPI Quality Engineer to act as a senior quality leader for new product introductions across our consumer technology lines.

You will define quality strategies, mentor teams, and partner with R&D, manufacturing, and suppliers to translate development programs into scalable production processes. You will drive IQ/OQ/PQ validation, SPC, FMEA, CAPA, and GD&T while ensuring compliance with GMP, FDA QSR, ISO 13485, and other 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.
• Demonstrated experience leading complex, cross-functional NPI programs or quality initiatives from development through production launch.
• Expertise in IQ/OQ/PQ, SPC, process capability, FMEA, 8D/root-cause analysis, CAPA, GD&T and statistical problem solving.
• Strong knowledge of quality system standards and regulatory compliance, including GMP, FDA QSR, and ISO 13485.
• Proficiency in metrology techniques and mechanical/metallurgical testing methods.
• Excellent communication skills with experience interfacing with suppliers and customers.

Responsibilities

• Lead quality strategy for major NPI programs, establishing quality objectives, risk-based plans, deliverables, and readiness criteria from early development through production ramp.
• Define and lead process validation, including IQ/OQ/PQ, process characterization, capability studies, and validation plans for additive manufacturing and downstream processes.
• 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.
• Drive product and process risk management strategies, including FMEA, control plans, process risk assessments, and mitigation plans throughout the NPI lifecycle.
• Develop and establish requirements for mechanical and metallurgical testing, including tensile testing, density, hardness, microstructural characterization, and other material performance evaluations for Ti-6Al-4V and high-temperature alloys.
• Establish scalable SPC and process monitoring frameworks, including critical process parameters, critical quality characteristics, control plans, capability targets, and ongoing assessment of process stability.
• Serve as a Material Review Board team member to evaluate and disposition of non-conformances.
• 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.

Skills

NPI quality

Quality engineering

Process validation

SPC

FMEA

8D / root-cause analysis

CAPA

GD&T

Metrology

Regulatory compliance

Statistical problem solving

Communication skills

Education

Bachelor's degree (Engineering or related)

Job description

VulcanForms Inc. is seeking a Staff NPI Quality Engineer to act as a senior quality leader for new product introductions across our consumer technology lines.

You will define quality strategies, mentor teams, and partner with R&D, manufacturing, and suppliers to translate development programs into scalable production processes. You will drive IQ/OQ/PQ validation, SPC, FMEA, CAPA, and GD&T while ensuring compliance with GMP, FDA QSR, ISO 13485, and other standards.