Senior Quality Engineer - Medical Devices, ISO 13485

Intepros; Norwood (MA); Presencial; USD 90 000 - 130 000; Tempo integral

Resumo da oferta

Intepros in Norwood, MA seeks a Senior Quality Engineer to support the effectiveness of our Quality Management System and ensure ISO 13485:2016 compliance. This role collaborates with Quality, Engineering, Operations, and Manufacturing to uphold regulatory standards and drive product quality improvements.

Hands-on quality engineering on the floor includes CAPA, nonconforming material, validation, and root cause investigations.

Qualificações

• 3 to 7 years of quality engineering experience in the medical device or regulated manufacturing sector.
• Strong working knowledge of ISO 13485:2016.
• Experience with CAPA, nonconforming material, root cause analysis, and corrective actions.
• Experience with equipment qualification and process validation (IQ, OQ, PQ).
• FMEA, risk management, First Article Inspection, and MSA familiarity.

Responsabilidades

• Support the maintenance and continuous improvement of the Quality Management System (QMS).
• Provide hands-on floor support, troubleshoot quality issues, and perform root cause analysis.
• Own CAPA activities, investigations, and effectiveness verification.
• Support equipment qualification and process validation (IQ/OQ/PQ).
• Collaborate with Engineering on validation protocols and testing.
• Manage nonconforming material activities and lead MRB processes.
• Perform First Article Inspections with Quality Control.
• Develop and execute Measurement System Analysis, including Gage R&R where applicable.
• Assist daily operations and CI initiatives to improve KPIs and manufacturing performance.
• Support supplier quality activities and performance feedback.
• Create and revise SOPs, work instructions, and quality documents.
• Provide input into FMEAs and risk management activities.
• Conduct product quality inspections as needed and assist calibration of measurement equipment.
• Deliver quality-related training to employees as needed.

Conhecimentos

Quality engineering

CAPA

FMEA

Gage R&R

Root cause analysis

Regulatory compliance

Formação académica

Bachelor's degree in Engineering, Quality, Manufacturing, or related field

Descrição da oferta de emprego

Intepros in Norwood, MA seeks a Senior Quality Engineer to support the effectiveness of our Quality Management System and ensure ISO 13485:2016 compliance. This role collaborates with Quality, Engineering, Operations, and Manufacturing to uphold regulatory standards and drive product quality improvements.

Hands-on quality engineering on the floor includes CAPA, nonconforming material, validation, and root cause investigations.