Quality Engineer

Wilson • Mahwah, NJ

2d • Hybrid

About The Position

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

Requirements

• Bachelor’s Degree - Biomedical Engineering, Mechanical Engineering or related field
• 1 + years of experience in industry required
• Knowledge of Change Management and Quality Management Systems (QMS) principles.
• 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.
• Self-starter with efficient work style and ability to handle multiple tasks in a fast-paced environment.
• Be willing to work as part of a multi-site team.
• Problem solving and analytical skills.
• Be able to build strong relationships by fostering open communications, respect and trust.
• Strong team player and acts with a customer service/stakeholder focused approach.
• Ability to be the voice of Quality when dealing cross functionally.
• Excellent English (both oral and written).

Nice To Haves

• Firm understanding of Med Device concepts highly desirable.
• Familiarity with ISO 13485, GDP, GMP concept highly desirable.
• Have knowledge of Risk Based and statistical concepts is desirable.

Responsibilities

• Product Transfers and Supplier Change Requests
• Production Part Approval Process (PPAP)
• Validation projects for new equipment and processes introduced to the plant.
• First Article Inspection (FAI) strategy development, execution, and approvals.
• Standard Operating Procedures (SOP) and Inspection plan creation and updates through the change management system.

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level