Senior Quality Engineer: Process & Compliance Leader

Comrise; Mahwah (NJ); On-site; USD 85,000 - 110,000; Full time

Job summary

Comrise is seeking a Senior Quality Engineer to deliver quality engineering support across QA, QC and preventative activities in operations. You will develop methods for process control, testing and inspection to ensure flaw-free products.

The role includes FAI strategy, PPAP, change control, and process validations, with a focus on compliance to ISO 13485 and EU regulations. Strong communication and MS Office skills are essential for success.

Qualifications

• Bachelor’s degree in Biomedical or Mechanical Engineering.
• 4+ years of industry experience.
• Knowledge of Change Management and QMS principles.
• Med Device concepts knowledge highly desirable.
• Familiarity with ISO 13485 and EU Regulations, GDP, GMP desirable.
• Excellent communication skills and attention to detail.
• Good understanding of engineering and quality concepts/theories.
• High level of PC skills; proficient with MS Word, Excel and PowerPoint.

Responsibilities

• Develop and implement FAI strategies and approvals.
• Lead PPAP and change control processes.
• Conduct change impact assessments and validations.
• Maintain SOPs and risk management documentation.
• Advocate initiatives to enhance quality performance and regulatory compliance.
• Support quality assurance, control and preventative activities.

Skills

FAI

PPAP

Change management

QMS

Med device concepts

ISO 13485

EU regulations

GDP / GMP

Communication

Attention to detail

Engineering fundamentals

MS Office

Education

Bachelor's Degree - Biomedical or Mechanical Engineering

Tools

Microsoft Word

Microsoft Excel

PowerPoint

Job description

Comrise is seeking a Senior Quality Engineer to deliver quality engineering support across QA, QC and preventative activities in operations. You will develop methods for process control, testing and inspection to ensure flaw-free products.

The role includes FAI strategy, PPAP, change control, and process validations, with a focus on compliance to ISO 13485 and EU regulations. Strong communication and MS Office skills are essential for success.