Quality Specialist
pPosition Summary /p pThe Quality Specialist is responsible for assisting in administration of the quality functions at a site to assure adherence to ISO 9001, ISO 13485, MDSAP, FDA 21 CFR Part 820/211, EU MDR and other applicable regulatory standards. This role coordinates document control transactions, site record retention, calibration and inspection activities. In addition, the Quality Specialist will facilitate Customer complaint investigations, assist in audit coordination, support supplier quality and customer assessments and support risk management activities where appropriate. This role may also track and trend Quality data and support the site Management Review process. /p h3Duties /h3 ul liComplete document control transactions. /li liManage Customer complaint investigations and complete complaint documentation. /li liFacilitate CAPA and NCR investigations and may coordinate investigation documentation. /li liReview DHR’s and support batch record release. /li liManage record retention practices within the site. /li liManage site calibration activities and recordkeeping.
/li liSupport site inspection activities and recordkeeping. /li liCoordinate internal and external audits. /li liSupport supplier quality and Customer assessment activities. /li liTrack and trend site Quality data. /li liSupport targeted Lean activities. /li liComplete other duties as assigned. /li /ul h3Education Degree /h3 pAssociate's Degree /p h3Required Experience Soft Skills /h3 ul liTwo (2) years experience in a regulated industry (i.e. FDA/ISO 13485) /li liDemonstrates a “Customer first” mindset. Responds with a sense of urgency. /li liCollaborates with others. Works in a professional manner to support team actions. /li liEffectively manages work tasks. /li liDetail oriented and strives for continuous improvement. /li liAbility to analyze technical issues. /li liAbility to cope with change and shifting priorities. /li liConstructs clear written communication. /li liKeeps manager and co-workers informed. /li /ul #J-18808-Ljbffr
/li liSupport site inspection activities and recordkeeping. /li liCoordinate internal and external audits. /li liSupport supplier quality and Customer assessment activities. /li liTrack and trend site Quality data. /li liSupport targeted Lean activities. /li liComplete other duties as assigned. /li /ul h3Education Degree /h3 pAssociate's Degree /p h3Required Experience Soft Skills /h3 ul liTwo (2) years experience in a regulated industry (i.e. FDA/ISO 13485) /li liDemonstrates a “Customer first” mindset. Responds with a sense of urgency. /li liCollaborates with others. Works in a professional manner to support team actions. /li liEffectively manages work tasks. /li liDetail oriented and strives for continuous improvement. /li liAbility to analyze technical issues. /li liAbility to cope with change and shifting priorities. /li liConstructs clear written communication. /li liKeeps manager and co-workers informed. /li /ul #J-18808-Ljbffr