Senior Quality Engineer

Senior Quality Engineer, Medical Devices

Our client, a market leader in biosurgery products, 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:

·        Bridgewater, 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.

Pay Rate Range: $60-$85/hr