Quality Assurance Engineer

Our client, a Global Leader in the Medical Device Industry, has an immediate opening for a Quality Assurance Engineer for a 12-month+ contract.  Our client offers results-driven people a place where they can make a difference - every day!  You will also have the opportunity to work with other like-minded, self-directed and detail-oriented Top Talents in an extremely collaborative and professional environment.  

As a 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 collaborate with the Manufacturing Engineering team, Sterility Assurance Teams, and Design Teams to land new equipment and set up the process for quality and compliance success by implementing appropriate, risk-based process controls and equipment maintenance measures.

Weekly Hybrid with a minimum 3 days a week onsite after onboarding is completed. 

Key Responsibilities:

• Validation projects for new equipment and processes introduced to the plant.
• First Article Inspection (FAI) strategy development, execution, and approvals.
• Standard Operation Procedures (SOP) and Inspection plan creation and updates through the change management system.
• And more.

Qualifications:

• 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.
• Firm understanding of Med Device concepts highly desirable.
• Familiarity with ISO 13485, GDP, and GMP concepts is 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.
• 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.
• Have knowledge of Risk Based and statistical concepts is desirable.
• 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).
• Up to 10% travel may be required