Description
QUALIFICATIONS:-Medical Device experience is required.
-Formal lead auditor training, auditing experience, and ASQ Certification is preferred.
-Must have capability to review, analyze, summarize and interpret quality systems data, draw conclusions, make appropriate decisions and recommendations, write reports.
-Proficiency in Microsoft Office, statistical anayslis, and experience implementing reporting tools.
-Outstanding communcation skills and ability to act as a liason between company and suppliers.
-Excellent writing, organization, and time management skills.
-Proven ability to identify problems and come up with solutions.
JOB DESCRIPTIONS:
-Responsible for conducting key objectives of the Supplier Quality Management program.
-Helps maintain a quality audit program that verifies supplier quality management systems are in compliance with 21 CFR Part 820, Good Manufacturing Practices, and international standards and requirements, such as ISO 13485, Medical Device Directives, Active Implantable Medical Device Directives, and Canadian Medical Device Regulations.
-Participates in various supplier quality management activities.
-Supports the supplier quality system to achieve high levels of efficiency, quality, and cost savings.
-Participates in the collection and analyzing of quality information from various quality systems and develops reports as needed for senior management review, and provides recommendations.
-Supports the initiation and completion of First Article Inspections in collaboration with the Receiving Inspection department, in order to verify that supplier production methods have produced parts that fully conforms to specified requirements.
-Develops and maintains specifications & SOP's in area of responsibility.
To find out more about Real please visit www.realstaffing.com