Senior Quality Engineer

4 weeks ago


Raritan, United States GForce Life Sciences Full time

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 Bachelor’s 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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