Quality Engineer II — Medical Device GMP/ISO Expert

Nordson Corporation; Salem (NH); Presencial; USD 85.000 - 115.000; Jornada completa

Descripción de la vacante

Nordson MEDICAL, a global leader in complex medical devices and components, seeks an experienced Quality professional to ensure GMP/GDP compliance and lead CAPA, SCAR, and process improvement across manufacturing operations.

You will participate in cross-functional teams, conduct root cause analysis, and prepare engineering studies while driving quality deliverables and waste reduction.

Formación

• Bachelor’s degree in engineering or related discipline is required; it may substitute for some of the years of required experience.
• Minimum of 5 years related experience preferably in the medical device industry.
• Knowledge of ISO 13485:2003, GMP, FDA, QSR.
• Strong root-cause investigator and problem solver within a manufacturing environment.
• Mechanical aptitude with manufacturing experience.

Responsabilidades

• Participate in multidisciplinary teams to implement root-cause analysis, corrective and preventive action, and proof of effectiveness as quality issues are identified.
• Design, execute and document gage R&R studies.
• Support training on Manufacturing and Quality System documents (SOPs, PIs, MAPs, QAPs).
• Actively lead process improvement events leading to reduction in cost of poor quality (COPQ).
• Reduce scrap and manufacturing waste for various product lines throughout the factory.
• Quality Representative for Material Review Board (NMR) for purchased and make components.
• Conduct and follow up of SCAR process (SCAR issuance, Supplier notification, SCAR approval and effectiveness review)
• Investigate and respond to customer complaints and customer issued SCARs.
• Quality Representative for Process Validations and Transfer Validations (may require writing, reviewing, executing, analyzing and reporting on test protocols).
• Prepare quality related deliverables in a timely manner.
• Prepare and execute Engineering studies as needed.
• Responsible for CAPA root cause investigation and actions implementation.
• Implementation of SPC.
• Eliminate All Escapes to the customer. Metric goal is zero.
• Creates Controls plans
• Meet KPI Goals,Quality deliverables.
• Support Quality Culture.
• Lean QMS initiative to reduce Muda by eliminating bureaucratic processes.
• Participate in Quality and Manufacturing Department meetings.
• Collaborate in the clarification of specifications for quality.
• Acts as a consultant for areas related to his/her expertise.
• Support Supplier management process as required.
• Participate and assist as a part of the Internal Audit team as required.
• Other duties as assigned, verbal and written.
• Follow medical device manufacturing best practices (GMP, GDP, etc.), current Nordson Medical policies and procedures, ISO 13485, 21CFR Part 820 and other applicable regulations to ensure compliance to applicable customer and regulatory requirements

Conocimientos

Root cause analysis

Problem solving

Quality systems

CAPA

SPC

Mechanical aptitude

Educación

Bachelor’s degree in engineering or related discipline

Descripción del empleo

Nordson MEDICAL, a global leader in complex medical devices and components, seeks an experienced Quality professional to ensure GMP/GDP compliance and lead CAPA, SCAR, and process improvement across manufacturing operations.

You will participate in cross-functional teams, conduct root cause analysis, and prepare engineering studies while driving quality deliverables and waste reduction.