Quality Systems & Regulatory Consultant (P-11212)

Medical Device Chicago, Illinois


• Responsible for the implementation of the Medical Device Regulation 2017/745
(MDR) at the client
• Responsible for the creation of documentation that reports issues/errors relating to quality
and/or production processes with demonstrated efforts to find a
• Contribute to formulate a strategic plan to increase and improve productivity in the business.

Summary of Essential Job functions:

• Ensure compliance with company policies and business practices including FDA (Food & Drug Administration)
Regulations, GMP (Drug and Device Manufacturing Practices),and ISO (International Organization for Standardization) Medical Device Quality System Requirements.
• Develop and implement Quality Systems as assigned by Quality Management.
•Implement MDR at Amsino
• Collaborate with Operations to develop and implement controls and improvements
• Develop corrective actions, solutions and improvements• Recurring physical demands include sitting, standing, walking, crouching, using tools, lifting up-to 15 pounds and on very rare occasion up
to 100 pounds.

Minimum Requirements
• Minimum of bachelor’s degree in quality, industrial or
mechanical engineering
• ASQ certification preferred
• 10+ years of experience in quality assurance, quality control or a
similar role. Including implementation of MDR.
• Strong analytical and problem-solving skills.
• Excellent project management skills
• Strong communication and interpersonal
Skill Requirements:
• Strong analytical and problem-solving skills
• Excellent project management skills
•Strong communication and interpersonal
skills to effectively communicate with all levels of the
• Proficient Computer skills (Word, Excel, etc)

•Detail oriented
• Analysis, critical thinking and problem-solving