Quality Engineer – Hybrid, PTO & Impact on Patient Care

Energy Jobline ZR; Stoughton (MA); Híbrido; USD 90.000 - 120.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Hybrid work schedule

401(k) retirement plan

Medical/Dental/Vision coverage

Paid time off

Descripción de la vacante

Amphenol Alden is seeking a Quality Engineer at our Stoughton, MA facility to maintain product quality, support customer requirements, and drive continuous improvement in manufacturing processes. You will collaborate with engineering to develop inspection plans, address nonconformances and CAPA, perform FAI and capability studies, and ensure compliance with ISO 13485 and FDA 21 CFR Part 820.

We offer a hybrid work schedule, a competitive benefits package including medical, dental, vision,

Formación

• At least 3 years of related experience in a manufacturing environment in a Quality Engineer role.
• Knowledge of ISO 13485:2016 and FDA medical device quality system requirements under 21 CFR Part 820.
• Familiarity with PFMEA, Process Control Plans, Process Maps and other quality/engineering processes.
• Knowledge of process validation including IQ, OQ, and PQ.
• Proficiency with Microsoft Office applications; Minitab is a plus.
• A four-year college degree, preferably in Engineering or related field, or equivalent hands-on experience.
• Strong organizational, communication, problem-solving, and analytical skills.
• Ability to travel to AAP facilities, suppliers, and customer locations, including international travel.

Responsabilidades

• Collaborate with Engineering to develop customer inspection plans and documentation packages.
• Address nonconformances, quality alerts, and CAPA with customers.
• Perform First Article Inspections (FAI), process capability (Cpk) studies, and GR&R studies.
• Support quality planning, process controls, and validation activities.
• Help ensure compliance with medical device regulations and customer requirements.

Conocimientos

Problem-solving

Analytical skills

Communication skills

Organizational skills

Educación

Four-year college degree in Engineering or related field

Herramientas

Minitab

Microsoft Word

Microsoft Excel

Microsoft PowerPoint

Descripción del empleo

Amphenol Alden is seeking a Quality Engineer at our Stoughton, MA facility to maintain product quality, support customer requirements, and drive continuous improvement in manufacturing processes. You will collaborate with engineering to develop inspection plans, address nonconformances and CAPA, perform FAI and capability studies, and ensure compliance with ISO 13485 and FDA 21 CFR Part 820.

We offer a hybrid work schedule, a competitive benefits package including medical, dental, vision,