Quality Assurance Engineer

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

As a Senior Quality Engineer, you will provide quality engineering support in quality assurance, control and preventative activities within operations and other business functions.

You will be tasked with developing and implementing methods and procedures for process control, process improvement, testing and inspection to ensure that the products are free of flaws and function as designed.

You will be expected to support:

• First Article Inspection (FAI) strategy development, execution, and approvals.
• Production Part Approval Process (PPAP)
• Change control processes and change impact assessments
• Equipment and Process validations
• SOP and Risk Management documentation updates and reviews
• And more

This is an individual contributor role that requires the use of judgement in applying professional expertise and is expected to work independently with minimal supervision. Roles typically require a university degree or an extensive amount of practical knowledge gained through experience. Job requires an understanding and application of procedures and concepts of own discipline. The job requires the ability to make judgements based on practice and previous experience.

You will advocate and lead the execution of initiatives & projects to enhance quality performance within the business and ensure compliance to regulations and standards.

Expected Qualifications:

• Bachelor’s Degree - Biomedical Engineering, Mechanical Engineering or related field
• 4 + years of experience in industry required
• Knowledge of Change Management and Quality Management Systems (QMS) principles.
• Firm understanding of Med Device concepts highly desirable.
• 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. Must be proficient with Microsoft Word, Microsoft Excel and PowerPoint packages.