Quality Engineer II — Process Improvement & Compliance

Spectrum Plastics Group; Wall (SD); On-site; USD 95,000 - 105,000; Full time

Job summary

Fermatex in Wall, NJ is seeking a Quality Engineer II to support process improvements and regulatory compliance for sustaining products. You will participate in design controls, audits, and nonconforming material investigations while guiding quality system activities and change controls.

The role requires strong root-cause analysis, knowledge of ISO 13485 and FDA QSR, and effective communication across cross-functional teams. On-site position with first shift responsibilities.

Qualifications

• Bachelor's degree in engineering or related discipline; may substitute for some experience.
• Well‑rounded knowledge of ISO 13485:2016 and FDA QSR.
• Strong root-cause investigator and problem solver within a manufacturing environment.
• Experienced with statistical analysis and data presentation.
• Certified Lead Auditor

Responsibilities

• Follow Quality System requirements and regulatory guidelines.
• Develop and validate protocols for process changes; report conclusions.
• Serve as Quality System process owner for key components.
• Investigate customer complaints and implement CAPA actions.
• Collaborate with Engineering to drive process improvements.
• Prepare quality deliverables and release documents via change control.

Skills

Statistical analysis

Quality auditing

Written communication

Problem solving

Education

Bachelor's degree in engineering or related discipline

Tools

Microsoft Excel

Microsoft Project

MS Office suite

Job description

Fermatex in Wall, NJ is seeking a Quality Engineer II to support process improvements and regulatory compliance for sustaining products. You will participate in design controls, audits, and nonconforming material investigations while guiding quality system activities and change controls.

The role requires strong root-cause analysis, knowledge of ISO 13485 and FDA QSR, and effective communication across cross-functional teams. On-site position with first shift responsibilities.