Quality Assurance Associate Engineer

Job Summary

A Quality Assurance Associate Engineer for a medical devices and equipment manufacturing company is needed in the Mahwah, NJ area. This role balances high-level system design with tactical execution of software validation, equipment qualification, and supplier management within a regulated medical device environment.

Mahwah, New Jersey

Contract

$46.42 - $53.57 per hour

8am to 5pm

Associates

• Responsible for the design, modeling, development, and testing of complex machines or systems.
• Develops functional requirements and applies standard engineering principles to project goals.
• Creates simulations and prototypes to evaluate preliminary designs and operational performance.
• Designs, tests, and integrates components into a finalized, functional product.
• Monitors product quality and implements controls for process efficiency.
• Evaluates designs based on effectiveness, cost-efficiency, reliability, and safety.
• Investigates root causes of failures to maintain quality and recommend design improvements.
• Designs the overall strategy for 2D Barcode implementation in alignment with EU MDR regulations.
• Develops high-level strategies for Equipment Qualification and Software Validation.
• Executes labeling implementations including GTIN, UDI, and GS1/HIBC requirements.
• Manages supplier relationships and coordinates technical requirements with external partners.

5 to 10 years of experience, or more.

• Experience designing validations.
• Experience with labeling implementation such as GTIN, UDI, EU MDR.
• Experience with GS1 and HIBC labeling requirements.
• Ability to work with suppliers.
• Change control implementation.
• Experience with PPAP.
• Quality
• Testing
• Engineering
• Validation

• Experience level:
  Experienced
• Education:
  
  Associates

Equal Opportunity

Employer:

Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.

At Randstad, we welcome people of all abilities and want to ensure that our hiring and interview process meets the needs of all applicants. If you require a reasonable accommodation to make your application or interview experience a great one, please contact

Pay offered to a successful candidate will be based on several factors including the candidate's education, work experience, work location, specific job duties, certifications, etc. In addition, Randstad offers a comprehensive benefits package, including: medical, prescription, dental, vision, AD&D, and life insurance offerings, short-term disability, and a 401K plan (all benefits are based on eligibility).

This posting is open for thirty (30) days.