Kelly Engineering is Hiring a Sr. Quality Engineer!

Deerfield Beach, FL | On-Site | $90-115K/YR

Overview

The position of the Senior Quality Engineer holds responsibility for the effectiveness and quality of product design and process developments ensuring its compliance with applicable regulations. The job holder is directly involved in the establishment and application of efficient design controls and risk management procedures and tools and actively cooperates with multiple departments.

Responsibilities

• Represent Global Quality Engineering in all Design Controls and Product Development related aspects
• Ensure the efficiency of Design Controls (Quality by Design) in projects
• Promote Advanced Product Quality Planning and ensure compliance with relevant standards
• Actively take part in/facilitate Product Development and Quality Planning processes improvement efforts
• Apply Quality Engineering principles in a dynamic way to development and production projects
• Utilize Quality Engineering best practices, ensuring internal and external customers’ needs and requirements are built into new products and future product changes
• Applies Quality Engineering tools, techniques and methodologies to product development according to the company’s needs and applicable regulations.
• Support Risk Management activities for medical devices and the device part of drug/device combination products for products are of high quality and directs product development decisions by promoting a Risk-Based approach.
• Support SMEs in the identification and traceability of CTQs
• Support studies performed on simulations, designs, manufacturing processes and a review of engineering experiments (DOEs) utilizing the results to make decisions affecting product and process development direction.
• Ensure all functions adhere to procedure’s requirements and standards during all development and manufacturing stages.

Requirements

• 5+ years Quality Engineering in Medical Device or Pharmaceuticals
• Knowledge of ISO 13485 and QSR, ISO 14971, IEC62366, IEC62304.
• Bachelor’s Degree