Senior QA Engineer CardioMEMS
THIS JOB HAS EXPIRED General Function:
Implementation and maintenance of internal Quality System and Current Good Manufacturing Practices for FDA and ISO compliance. Responsible for quality assurance at CardioMEMS and supplier sites. Lead quality initiatives and support QA department staff.
Major Duties & Responsibilities:
1.Maintain an intimate knowledge of Quality Systems and Current Good Manufacturing Practices, and ensure compliance internally and by suppliers.
2.Maintain an intimate knowledge of and ensure compliance to required CardioMEMS Quality SOP?s.
3.Lead key Quality System activities including CAPA, Field Assurance (customer complaints), Design Control, Document Control, Employee Training, Supplier Management, and internal SOP requirements.
4.Monitor the effectiveness and ensure continuous improvement of quality system processes and procedures that support the organization and regulatory compliance.
5.Support internal production inspection and acceptance activities as well as process validation activities.
6.Provide oversight of statistical sampling for internal and external quality control and process/product validation protocol statistical support.
7.Support the Research & Development team with Design Control activities including product and software Design Verification & Validation, Design Transfer, and commercialization release.
8.Perform internal audits and supplier audits against GMPs, ISO 13485, CMDCAS and/or any other applicable regulations.
9.Support quality activities for external suppliers.
10.Actively participate with external (FDA, ISO, 3rd parties) quality system audits.
11.Support QA Engineer and Technician staff as needed.
12.Provide a backup for Quality Manager responsibilities as needed.
?5 Years minimum quality assurance experience in the medical device or related industry, or demonstrated ability to perform job requirements
?B.S. Degree in technical, business or related discipline. B.S. or M.S. in engineering is a plus.
?ASQ certification a plus.
?Proficient with the QSR (including Design Controls), Medical Device Directive, CMDCAS and ISO Quality System Standards.
?Strong analytical, decision-making and problem solving skills.
?Proficient in the use of appropriate cause analysis tools and techniques such as root cause analysis, FMEA, DOE a strong plus.
?Experience with conducting audits.
?Excellent communication skills.
||387 Technology Circle Northwest |
Atlanta, GA 30313
THIS JOB HAS EXPIRED