Quality Engineer II - Process & CAPA Leader

Spectrum Plastics Group; United States; Sur place; USD 70 000 - 100 000; Plein temps

Résumé du poste

Spectrum Plastics Group is seeking a Quality Engineer II to support process improvements, risk management, complaint handling, design control, and audits across sustaining products. The role requires working with cross-functional teams to ensure compliance with ISO 13485 and FDA QSR.

The engineer will review quality system documents, write and approve procedures, and act as a quality system owner for key processes including NCRs, CAPAs, internal audits, and supplier quality.

Qualifications

• Bachelor's degree in engineering or related discipline.
• ISO 13485:2016 and FDA QSR knowledge.
• 3–8 years in a regulated industry.
• Strong root-cause investigation skills.
• Experience with process validation and CAPA.

Responsabilités

• Follow Quality System requirements and company procedures to meet regulatory requirements.
• Develop validation/verification protocols for process changes and report conclusions.
• Conduct customer complaint investigations and implement corrective actions.
• Interface with Engineering for continual improvement of manufacturing processes.
• Prepare quality deliverables and manage change control releases.

Connaissances

Root cause analysis

Statistical analysis

Written communication

Problem solving

Data analysis

Formation

Bachelor's degree in engineering

Outils

Excel

Microsoft Project

Outlook

Word

Windows OS

Description du poste

Spectrum Plastics Group is seeking a Quality Engineer II to support process improvements, risk management, complaint handling, design control, and audits across sustaining products. The role requires working with cross-functional teams to ensure compliance with ISO 13485 and FDA QSR.

The engineer will review quality system documents, write and approve procedures, and act as a quality system owner for key processes including NCRs, CAPAs, internal audits, and supplier quality.