Senior NPI Quality Engineer, Additive Manufacturing

VulcanForms Inc.; Ayer (MA); Vor Ort; USD 117.000 - 162.000; Vollzeit

Benefits dieser Stelle

Medical insurance

401(k) match

Paid time off

Dental & vision insurance

Life insurance

Zusammenfassung

VulcanForms Inc. seeks a Staff NPI Quality Engineer to lead quality strategy for new product introductions across our consumer technology line.

You will partner with R&D, Manufacturing, Operations, Suppliers, and customers to transition advanced metal additive products from development to robust, scalable production. You will mentor other quality engineers, influence technical direction, and apply statistical methods, process validation, and manufacturing know‑how to ensure product quality and

Qualifikationen

• Bachelor’s degree in Engineering or related field; equivalent hands‑on experience considered.
• 6+ years of quality engineering experience in advanced manufacturing or additive manufacturing.
• Led cross‑functional NPI quality programs from development to production launch.
• Expertise in IQ/OQ/PQ, SPC, process capability, FMEA, 8D/root‑cause, CAPA, GD&T, and statistical problem solving.
• Strong knowledge of GMP, FDA QSR, and ISO 13485 compliance.
• Excellent communication skills with suppliers and customers.

Aufgaben

• Lead quality strategy for major NPI programs from development through production ramp.
• Define and lead process validation activities (IQ/OQ/PQ) and validation plans.
• Monitor performance metrics and drive continuous improvement for quality and efficiency.
• Support supplier quality including audits and qualification activities.
• Drive risk management with FMEA, control plans, and mitigation strategies.
• Define testing requirements for mechanical/metallurgical properties (Ti-6Al-4V, high temp alloys).
• Establish SPC frameworks, CPPs, CQC, and capability targets; monitor stability.
• Participate as MRB member for non‑conformances and resolve issues.

Kenntnisse

Quality leadership

Process validation IQ/OQ/PQ

GMP / FDA QSR knowledge

Metrology skills

Strong communication

Ausbildung

Bachelor’s degree in Engineering or related field

Tools

GD&T

CAPA tools

Jobbeschreibung

VulcanForms Inc. seeks a Staff NPI Quality Engineer to lead quality strategy for new product introductions across our consumer technology line.

You will partner with R&D, Manufacturing, Operations, Suppliers, and customers to transition advanced metal additive products from development to robust, scalable production. You will mentor other quality engineers, influence technical direction, and apply statistical methods, process validation, and manufacturing know‑how to ensure product quality and