Quality Process Validation Lead

Ultralife Manufacturing USA; Raynham (MA); On-site; USD 80,000 - 110,000; Full time

Job summary

Ultralife Manufacturing USA seeks a Quality Engineer to ensure compliant manufacturing quality, lead investigations, validate test methods, and drive CAPA effectiveness. You will coordinate validations with Design and Manufacturing Engineers, review changes to specs and drawings, and mentor 1–3 technicians/inspectors while collaborating with suppliers and other teams.

The candidate should have 2–5 years' QA experience, working knowledge of ISO/QSR/UL, and strong communication skills.

Qualifications

• 2–5 years of quality engineering experience in manufacturing.
• Hands-on experience with quality engineering tools and techniques.
• Working knowledge of domestic and international regulations and standards (ISO, QSR, UL, MDD, TGA, etc.).
• Proficiency with Microsoft Office and statistical software (Minitab).
• Clear written and verbal communication; capable of independent and team work.
• Preferred certifications (CQE, CSQE, CRE) are a plus.

Responsibilities

• Lead investigations into deviations, nonconformances, and CAPA.
• Review and approve changes to BOMs, specifications, drawings, and FMEAs.
• Own test method validations from protocol to final report.
• Coordinate process validations and capability studies with Design and Manufacturing Engineers.
• Write, approve, and implement incoming, in-process, and final inspection procedures.
• Mentor 1–3 technicians/inspectors and support supplier quality activities.

Skills

Quality engineering

CAPA

GxP/regulatory knowledge

Minitab

Root cause analysis

Statistical methods

Education

Bachelor’s degree in Engineering

Tools

Minitab

DOE

FMEA

Job description

Ultralife Manufacturing USA seeks a Quality Engineer to ensure compliant manufacturing quality, lead investigations, validate test methods, and drive CAPA effectiveness. You will coordinate validations with Design and Manufacturing Engineers, review changes to specs and drawings, and mentor 1–3 technicians/inspectors while collaborating with suppliers and other teams.

The candidate should have 2–5 years' QA experience, working knowledge of ISO/QSR/UL, and strong communication skills.