Quality Systems & Regulatory Consultant

Location: Chicago, IL
Department: Azzur Consulting LLC

Job Description

Do What You Love

At Azzur, we look for talented individuals who take pride in the work they do. We foster employee growth by encouraging our employees to focus on doing what they love and what they do best.

Azzur is a GxP compliance and consulting organization dedicated to providing high quality, expertly backed, assistance that drives life science companies to success.  We are seeking highly motivated and talented individuals to join our incredible team of skilled problem solvers.  Qualified candidates must have a desire to learn, apply, engage, and adapt in the ever-changing healthcare field while simultaneously and organically exuding Azzur’s core values:

Put Others First, Courage to Take Action, Take Personal Responsibility and Have Fun!

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 
• 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 skills

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 organization
• Proficient Computer skills (Word, Excel, etc)
Detail oriented Analysis, critical thinking and problem-solving skills 


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