Quality Engineer
Company Name:
Randstad Engineering
A leader in innovative products and complete solutions in the healthcare industry is currently seeking a Quality Response Engineer to perform complaint handling quality monitoring processes in the Newark, DE area. This is a 9 month CONTRACT position, with the possibility of extension. Local candidates only. No per diem is available for this assignment.
Responsibilities for the Quality Engineer
Review complaint files and associated documentation, and assure that all presented product complaints are documented in a thorough and precise manner with an emphasis on identifying reportable incidents
Provide feedback and/or input in regard to complaint files and/or supporting documentation not meeting complaint handling documentation requirements
Collect and demonstrates knowledge in analyzing relevant evidence that permits drawing conclusions with respect to the Complaint System and other objectives.
Applies knowledge of medical device and vigilance reporting to assess whether applicable complaints are communicated to Quality Management by the Complaint Handling Unit
Requirements for the Quality Engineer
Minimum BA/BS degree in science or other technical field (3-5 years experience)
Experience in customer complaint processes in medical devices/pharmaceutical industry
Knowledge of FDA Quality Systems Regulations 820 (complaint handling, CAPA) Medical Device Reports 803, Corrections and Removals part 806
ISO Quality Management System requirements is a plus
Benefits for the Quality Engineer
401K
Health Insurance, and much more
Related Words: engineer, engineering, complaint handling, quality monitoring, diagnostic products, product complaints, fda, quality system regulations, capa, medical device report 803, corrections and removal 806, potential vigilance report, qsr 820
Company Description:
Randstad is a $22.5 billion global provider of HR services and the second largest staffing organization in the world. From temporary staffing to permanent placement to in-house, professionals, search & selection, and HR Solutions, Randstad holds top positions around the world and has approximately 31,100 corporate employees working from its nearly 4,700 branches and in-house locations in 40 countries.
We are a company built on a deep network of expertise that crosses industries and geographies. We recognize that talent comes in different forms, that every business has its unique challenges and opportunities. And our recruiting experts are skilled at marrying talent and business--identifying the ideal professionals for an organization's culture and its teams, its needs and its goals.Estimated Salary: $20 to $28 per hour based on qualifications.
Randstad Engineering
A leader in innovative products and complete solutions in the healthcare industry is currently seeking a Quality Response Engineer to perform complaint handling quality monitoring processes in the Newark, DE area. This is a 9 month CONTRACT position, with the possibility of extension. Local candidates only. No per diem is available for this assignment.
Responsibilities for the Quality Engineer
Review complaint files and associated documentation, and assure that all presented product complaints are documented in a thorough and precise manner with an emphasis on identifying reportable incidents
Provide feedback and/or input in regard to complaint files and/or supporting documentation not meeting complaint handling documentation requirements
Collect and demonstrates knowledge in analyzing relevant evidence that permits drawing conclusions with respect to the Complaint System and other objectives.
Applies knowledge of medical device and vigilance reporting to assess whether applicable complaints are communicated to Quality Management by the Complaint Handling Unit
Requirements for the Quality Engineer
Minimum BA/BS degree in science or other technical field (3-5 years experience)
Experience in customer complaint processes in medical devices/pharmaceutical industry
Knowledge of FDA Quality Systems Regulations 820 (complaint handling, CAPA) Medical Device Reports 803, Corrections and Removals part 806
ISO Quality Management System requirements is a plus
Benefits for the Quality Engineer
401K
Health Insurance, and much more
Related Words: engineer, engineering, complaint handling, quality monitoring, diagnostic products, product complaints, fda, quality system regulations, capa, medical device report 803, corrections and removal 806, potential vigilance report, qsr 820
Company Description:
Randstad is a $22.5 billion global provider of HR services and the second largest staffing organization in the world. From temporary staffing to permanent placement to in-house, professionals, search & selection, and HR Solutions, Randstad holds top positions around the world and has approximately 31,100 corporate employees working from its nearly 4,700 branches and in-house locations in 40 countries.
We are a company built on a deep network of expertise that crosses industries and geographies. We recognize that talent comes in different forms, that every business has its unique challenges and opportunities. And our recruiting experts are skilled at marrying talent and business--identifying the ideal professionals for an organization's culture and its teams, its needs and its goals.Estimated Salary: $20 to $28 per hour based on qualifications.
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