Our client is a pioneering medical technology company dedicated to advancing patient care through innovative solutions. With a rich history spanning over five decades, they have established themselves as a global leader in the design and manufacture of high-quality medical devices.

We are looking for a Quality Assurance Specialist to join our client's expanding team onsite in Alpharetta, GA. This person should have experience with quality standards, documentation, procedures, and quality assurance. The Quality Assurance Specialist will interact with customers and participate in regulatory inspections, client audits, and internal audits.

Requirements of the Quality Assurance Specialist:

• High school degree or higher
• 2+ years experience with quality procedures, standards, documentation, and quality assurance
• Excellent written and verbal communication skills
• Experience in a FDA regulated industry, medical device highly preferred

Responsibilities of the Quality Assurance Specialist:

• Adhere to company policies, procedures, and training requirements.
• Aid in developing quality assurance policies, standards, and processes.
• Support Production department in process validation and equipment qualifications.
• Assist in managing complaints by reviewing, investigating, and responding to customer or third-party complaints.
• Collaborate with QA/R Manager on root cause analysis and corrective actions for complaints.
• Participate in new supplier approvals and review nonconforming product for disposition.
• Maintain, distribute, and document controlled documents and records for the Quality Management System.
• Conduct qualification, calibration, and re-certification of cleanroom and equipment.
• Analyze data, prepare reports, and support Quality Management in developing action plans.
• Provide ongoing support for Quality Assurance team activities and assist in meeting daily goals and metrics.

Occupational Category: 19-4099.01 - Quality Control Analysts