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Senior Quality Engineer
1 month ago
Senior Quality Engineer, Medical Devices
Our client has engaged GForce to identify a Senior Quality Engineer with in-depth understanding of medical device quality system requirements, with specific experience in applying the following: Medical Device product risk management, Medical devices process validation, and Medical Device Design Control.
Responsibilities:
Lead and support quality engineering activities related to biosurgery medical devices.
Develop and implement risk management strategies for product development and lifecycle management.
Oversee and execute process validation activities to ensure compliance with regulatory standards.
Drive adherence to design control processes throughout product development lifecycle.
Collaborate with cross-functional teams to identify quality improvement opportunities and drive corrective actions.
Participate in audits and inspections to ensure compliance with regulatory requirements.
Mandatory Requirements:
A Bachelors degree in Engineering, Biology, Science, Chemistry, or related technical field is required.
Minimum of 4 years work experience in a regulated industry (medical device, biopharmaceutical, or pharmaceutical).
Fundamental understanding of the Quality Systems Regulations (QSR), including Design Control, and Good Manufacturing Practices (GMP).
Strong background in applying medical device quality system requirements, with specific expertise in product risk management, process validation, and design control.
Experience presenting to leadership.
Applied experience with documentation and technical writing skills, in a regulated compliance environment.
Ability to be ONSITE at least 3 days per week and upon request of management.
Preferred Requirements:
Advanced Degree
Prior experience in a Quality / Quality Engineering role.
Fundamental understanding of the pharmaceutical GMPs.
Experience in statistical analysis and statistical analysis tools such as Minitab is preferred.
Experience in applying various risk management and risk mitigation tools.
Experience with Test Method Validations, Root Cause Analysis, CAPA & Non-Conformance Management, and Process Validations.
Location and Availability:
Raritan, NJ
Resources should be available to work from the site for at least three days per week, with flexibility to work on-site as required by business needs.
Start within approximately three weeks from the offer date.
12 month contract
Pay Rate Range: $60-$80/hr
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