Senior Quality Engineer - NPI & Validation Expert

TRIAD Engineering Corp; Fitchburg (MA); Presencial; USD 90.000 - 130.000; Jornada completa

Descripción de la vacante

TRIAD Engineering Corp seeks an experienced Quality Engineer to support new product introduction, process validation, and quality improvement initiatives. This role collaborates with Engineering, Operations, and Quality teams to ensure products and processes meet customer, regulatory, and quality requirements.

The ideal candidate has hands-on validation experience, can independently lead validation activities, and acts as a technical resource for others.

Formación

• 5+ years of Quality Engineering experience in manufacturing.
• Demonstrated experience independently developing IQ/OQ/PQ protocols from scratch.
• Hands-on experience with Gage R&R, statistical sample size determination, and AQL.
• Strong knowledge of process validation, SPC, and statistical analysis.
• Proficiency with Minitab.
• Experience with PFMEA, root cause analysis, and CAPA.
• Working knowledge of ISO 9001 or ISO 13485.
• Ability to interpret engineering drawings and technical specifications.
• Strong communication, problem-solving, and cross-functional collaboration skills.
• Ability to independently drive validation activities and provide technical guidance.

Responsabilidades

• Independently develop, execute, and document IQ/OQ/PQ validation protocols.
• Lead process validations, equipment qualifications, and test method validations.
• Determine validation sample sizes and establish acceptance criteria.
• Conduct Gage R&R studies, process capability analyses, and statistical evaluations.
• Apply Minitab, SPC, and AQL sampling methodologies.
• Support quality activities throughout new product introduction (NPI).
• Review engineering drawings, specifications, and manufacturing documentation.
• Develop inspection methods, sampling plans, and quality requirements.
• Investigate nonconformances and customer complaints; drive root cause analysis and CAPA.
• Collaborate with Engineering, Operations, Tooling, and Quality teams to resolve issues.
• Ensure compliance with ISO 9001, ISO 13485, and applicable regulatory requirements.
• Support internal and external audits and maintain quality documentation.
• Serve as a technical resource and provide guidance to other team members.

Conocimientos

IQ/OQ/PQ protocols

Process validation

SPC

Gage R&R

Root cause analysis

CAPA

ISO 9001/13485

Engineering drawings

Cross-functional collaboration

Educación

Bachelor's degree in Engineering or related

ASQ CQE certification

Lead Auditor training

Herramientas

Minitab

Descripción del empleo

TRIAD Engineering Corp seeks an experienced Quality Engineer to support new product introduction, process validation, and quality improvement initiatives. This role collaborates with Engineering, Operations, and Quality teams to ensure products and processes meet customer, regulatory, and quality requirements.

The ideal candidate has hands-on validation experience, can independently lead validation activities, and acts as a technical resource for others.