Quality Engineer - Medical Device
Sterling Life Sciences - Raleigh, NC

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1) Implement and maintain effective quality systems in accordance with FDA quality systems regulation (ISO 9001, ISO 13485) and other applicable country specific regulations
2) Perform and/or support quality investigation activities (i.e., NCMR, NC and CAPAs)
3) Work across functions to investigate and close quality investigations
4) Act as lead investigator
5) Lead and participate in CAPAs resulting from quality investigations and internal quality audits and other relevant quality functions
6) Review/approve change request and participate in quality improvement initiatives and document revisions
7) Provide quality support on the production areas by coordinating and executing quality investigation and maintain relevant documentation to ensure compliance with company procedures
8) Participate in plant CAPA activities, including analysis of data and trends in complaints, supplier quality, nonconforming material, training effectiveness and root-causes analysis
9) Coordinate implementation of corrective actions and preventive measures
10) Track/Report status of investigations and escalate concerns to management on a timely basis
11) Support internal/external audits as needed
12) Ensure continuous improvement in projects
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1) University degree is required (preference will be given to those with degree in relevant field, though all candidates are welcome and encouraged to apply)
2) Appropriate full-time work experience is mandatory (no students or fresh graduates please)
3) Recent experience in the biotechnology industry is strongly preferred
4) Preference will be given to people who have recent experience in quality engineering