Senior Quality Engineer - Medical Devices | Hybrid

Impact Business Group; Mahwah (NJ); Hybride; USD 85 000 - 110 000; Plein temps

Avantages offerts par ce poste

Hybrid work model

Résumé du poste

Impact Business Group is seeking a Quality Engineer for a 12-month+ contract on 1st shift (Mon-Fri, 8:00 AM-5:00 PM ET). The role is hybrid with 3 days onsite in Mahwah, NJ, within the medical device industry.

The engineer will provide QA/QC support, develop process controls, and lead quality initiatives across operations and other functions. The position entails managing PPAP, leading validation efforts for new equipment and processes, and driving improvements through SOPs and inspection

Qualifications

• Quality assurance, control and preventative activities experience.
• Experience developing and implementing methods and procedures for process control.

Responsabilités

• Providing quality engineering support in QA, QC and preventative activities within operations and other business functions.
• Developing and implementing methods and procedures for process control, process improvement, testing and inspection.
• Advocating for and leading initiatives to enhance quality performance while ensuring regulatory compliance.
• Supporting product transfers and supplier change requests with necessary activities and documentation.
• Managing the Production Part Approval Process (PPAP) to verify and approve new or modified parts.
• Leading validation projects for new equipment and processes introduced to the plant.
• Developing, executing, and obtaining approvals for First Article Inspection (FAI) strategies.
• Creating and updating SOPs and inspection plans through the change management system.

Description du poste

Impact Business Group is seeking a Quality Engineer for a 12-month+ contract on 1st shift (Mon-Fri, 8:00 AM-5:00 PM ET). The role is hybrid with 3 days onsite in Mahwah, NJ, within the medical device industry.

The engineer will provide QA/QC support, develop process controls, and lead quality initiatives across operations and other functions. The position entails managing PPAP, leading validation efforts for new equipment and processes, and driving improvements through SOPs and inspection