Senior Quality Engineer - Medical Devices

Nordson Industrial Coating Systems; Salem (NH); On-site; USD 90,000 - 130,000; Full time

Job summary

Nordson Medical seeks an experienced Quality/Manufacturing professional to enforce GMP and FDA QSR standards across manufacturing operations. You will lead root-cause analyses, CAPA, gage R&R studies, and process validations while reducing COPQ and scrap.

You will design and document quality systems, train teams, and drive continuous improvement in a dynamic environment. Ideal candidates hold a BS in engineering, 5+ years in medical devices, and strong knowledge of ISO 13485:2003, GMP, and

Qualifications

• Bachelor's degree in engineering or related discipline.
• 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.

Responsibilities

• 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.

Skills

Root-cause analysis

Problem solving

Mechanical aptitude

Manufacturing experience

Education

Bachelor's degree in engineering or related discipline

Job description

Nordson Medical seeks an experienced Quality/Manufacturing professional to enforce GMP and FDA QSR standards across manufacturing operations. You will lead root-cause analyses, CAPA, gage R&R studies, and process validations while reducing COPQ and scrap.

You will design and document quality systems, train teams, and drive continuous improvement in a dynamic environment. Ideal candidates hold a BS in engineering, 5+ years in medical devices, and strong knowledge of ISO 13485:2003, GMP, and