Akkodis is seeking a Medical Device CAPA Specialist for a contract job with a client in Denver, CO. The primary job responsibility of this position is to oversee the record of the Corrective/Preventive Action, and Complaint Handling. Will assist, organize and report on processing, trending, and maintenance of the select quality system programs that include but may not be limited to: Change Control, Corrective/Preventive Action and Complaints Handling.
Salary Range: $41.81/hour to $45.29/hour. The salary may be negotiable based on experience, education, geographic location, and other factors.
Medical Device CAPA Specialist job responsibilities include:
• Interfacing with leader’s to assist in administration and transition to Global CAPA Procedures & Systems (ETQ)
• Performing administrative duties including monitoring of problem statements, root cause analysis, corrections, corrective and preventive actions, tracking timelines, and managing CAPA files
• Maintaining and revising applicable procedures
• Assisting/interfacing with CAPA owners on investigations and action plans • Create construction documents in AutoCAD and develop 3D models in AutoCAD Plant 3D
• Potentially owning CAPAs
Desired Qualifications:
• Bachelor's degree
• Two years in a Quality role within the medical device field
• Knowledge of structural design, lifting and support capacities, and regulatory requirements
• Knowledge of FDA regulations, ISO 13485 standards, and Medical Device Directive
• Experience owning/managing CAPAs
• Conducting training on root cause investigation and problem-solving techniques
• Experience with Windchill PLM or similar
If you are interested in this role, then please click APPLY NOW. For other opportunities available at Akkodis, or any questions, feel free to contact me at rod.grays@akkodisgroup.com
Equal Opportunity Employer/Veterans/Disabled
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The Company will consider qualified applicants with arrest and conviction records in accordance with federal, state, and local laws and/or security clearance requirements, including, as applicable:
· The California Fair Chance Act
· Los Angeles City Fair Chance Ordinance
· Los Angeles County Fair Chance Ordinance for Employers
· San Francisco Fair Chance Ordinance
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