Lead Product Quality Engineer, Industrials

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

Benefits offered by this job

Medical insurance

Dental insurance

Vision insurance

Life insurance

401(k)

Job summary

VulcanForms Inc. in Newburyport, MA is seeking a Lead Product Quality Engineer, Industrials to own quality strategy and execution for customer programs.

You will set the technical standard for quality systems, mentor engineers, and represent quality in cross-functional product development and ongoing production. You will drive IQ/OQ/PQ validations, CAPAs, and CTQ metrics, work under AS9100/ISO13485, and partner with Manufacturing, Process, and Machine Engineering to embed quality by design

Qualifications

• 8+ years of progressive quality engineering experience in a highly regulated manufacturing environment.
• Bachelor’s degree in Engineering, Materials Science, or related field.
• Mastery of FAIRs, process capability studies, and formal risk management tools (DFMEA/PFMEA).
• Hands‑on experience with AS9100 or ISO13485 quality systems.
• Familiarity with metals, metallurgy, machining, or metal additive processes.
• ASQ CQE/CRE or Six Sigma Green/Black Belt a plus.

Responsibilities

• Lead quality engineering for designated product lines through lifecycle from validation to production.
• Perform IQ/OQ/PQ validations for NPI and expansions.
• Investigate non-conformances, drive MRBs and CAPAs to eliminate root causes.
• Deploy and monitor SPC, define CTQ metrics, optimize metrology/testing on the factory floor.
• Create and approve DHFs, DMRs, DHRs to maintain audit readiness.
• Collaborate with Manufacturing, Process, and Machine Engineering on quality controls and DFM.
• Mentor and develop junior quality engineers and inspectors.

Skills

Quality engineering

Regulated manufacturing

CAPA implementation

Education

Bachelor's degree in Engineering or Materials Science

Tools

AS9100 / ISO13485

DFMEA/PFMEA

FAIRs

Job description

Job Purpose

VulcanFormsis hiring a Lead Product Quality Engineer, Industrials to own quality strategy and execution for customer programs within our Industrials business unit. You will set the technical standard for quality systems and process control within our high-tech digital production environment. This role goes beyond individual task execution to shape how quality is built into the program from the outset, mentor and develop other quality engineers supporting the program, and represent quality engineering in cross-functional product development & ongoing production initiatives.This role is based in Newburyport, MA with occasional travel to our Devens, MA facility.

Key Responsibilities

• Serve as the primary quality engineering lead for designated product lines, managing product lifecycle quality frominitialvalidation through steady-state production.
• Lead and execute comprehensive process validations and verification activities (IQ/OQ/PQ) for new product introductions (NPI) and existing line expansions.
• Independently investigate complex product non-conformances (NCRs), lead material review boards (MRBs), and drive the execution of Corrective and Preventive Actions (CAPAs) toeliminatesystemic failure modes.
• Own the deployment and monitoring of SPC frameworks, defining critical-to-quality (CTQ) metrics andoptimizingmetrology and testing protocols across the factory floor.
• Author, review, and approve critical quality system documentation (including DHFs, DMRs, and DHRs) tomaintaincontinuous audit readiness.
• Partner with Manufacturing, Process, and Machine Engineering teams during normal business hours to implement proactive quality controls and design-for-manufacturability initiatives.
• Build a high, performing team byprovidingtechnical guidance, coaching, and peer reviews for junior quality engineers and inspection technicians

Qualifications

• 8+ years of progressive quality engineering experience within a highly regulated advanced manufacturing environment
• Bachelor’s degree in Engineering, Materials Science, or a related technical field preferred.
• Proven mastery of First Article Inspection Reports (FAIRs), process capabilitystudies ,and formal risk management tools (DFMEA/PFMEA).
• Hands‑on experience working under AS9100 or ISO13485quality management systems.
• Familiarity with metal alloys, metallurgy, precision machining, or metal additive manufacturing processes.
• ASQ certifications (CQE, CRE) or Six Sigma Green/Black Belt a plus

VulcanFormsoffers a competitive salary and equitypackage.Actual compensation is based on factors such as the candidate’s skills, qualifications, and experience.In addition,VulcanFormsprovides comprehensive benefits including medical, dental, vision, and life insurance; generous paid time off; and a 401(k) plan with companymatch.

The annual base salary range for this position is $117,400 to $161,500.