Senior Quality Engineer - Onsite Impact & Compliance

Ledgent Technology; Mahwah (NJ); Sur place; USD 50 000 - 83 000; Plein temps

Résumé du poste

Ledgent Technology is seeking a Senior Engineer, Quality Assurance Engineering for an onsite role in Mahwah, NJ. You will provide quality engineering support across QA, control and preventative activities within operations and other business functions.

You will develop methods for process control, testing and inspection to ensure products are free of flaws and function as designed, while leading FAI/PPAP and change-control initiatives.

Qualifications

• Bachelor's Degree in Biomedical Engineering, Mechanical Engineering or related field.
• Experience supporting EU-MDR programs.
• Knowledge of Change Management and Quality Management Systems (QMS) principles.
• Familiarity with ISO 13485 and EU Regulations, GDP, GMP concept highly desirable.
• Excellent communication skills and attention to detail.
• Good understanding of engineering and quality concepts / theories.
• High level of PC skills. Proficient with Word, Excel and PowerPoint.
• Willingness to travel up to 10%.

Responsabilités

• Support First Article Inspection (FAI) strategy development, execution and approvals.
• Contribute to PPAP and change control processes and impact assessments.
• Assist with equipment and process validations and risk management documentation.
• Maintain SOPs and QA documentation updates and reviews.
• Advise on quality improvements and regulatory compliance across sites.

Connaissances

Excellent communication

Attention to detail

Problem solving

Analytical skills

Self-starter

Formation

Bachelor's Degree in Biomedical Engineering

Bachelor's Degree in Mechanical Engineering

Outils

Microsoft Word

Microsoft Excel

PowerPoint

Description du poste

Ledgent Technology is seeking a Senior Engineer, Quality Assurance Engineering for an onsite role in Mahwah, NJ. You will provide quality engineering support across QA, control and preventative activities within operations and other business functions.

You will develop methods for process control, testing and inspection to ensure products are free of flaws and function as designed, while leading FAI/PPAP and change-control initiatives.