R&D Engineer / Quality Engineer / OR mechanical engineer

Title : R&D Engineer / Quality Engineer / OR mechanical engineer

Duration : Longterm :

Location : Irvine,CA

Need experience interacting with marketing to ensure their claims are valid with the products.

Position Summary :

We are seeking a highly experienced Level III Quality Systems Engineer to join our Quality and Regulatory team. This role is critical in ensuring the integrity and compliance of marketing claims associated with our medical devices. The ideal candidate will have a strong background in quality systems within the medical device industry and a proven ability to trace marketing claims to supporting engineering analyses and documentation. This individual will also be responsible for developing and maintaining SOPs related to the establishment and validation of marketing claims, with a focus on different user populations.

In addition, this role will involve collecting and reviewing existing documentation to identify and substantiate claims, and later, training key stakeholders on the newly developed claims process to ensure consistent understanding and implementation across the organization.

Key Responsibilities :

• Marketing Claims Validation :
• Collect and review existing internal documentation to identify potential marketing claims.
• Organize and document findings to support traceability and validation efforts with internal project team.
• Investigate and validate marketing claims by tracing them to engineering analyses, risk assessments, and supporting technical documentation.
• Evaluate claims for accuracy, scientific validity, and compliance with regulatory standards (e.g., FDA, ISO 13485).
• Assess claims made for different user populations to ensure appropriate substantiation.
• Traceability and Documentation :

Utilize Pepper Flow software to manage and maintain traceability of claims to source documentation.

Develop, implement, and maintain Standard Operating Procedures (SOPs) for the creation, review, and approval of marketing claims.

Partner with Regulatory Affairs to ensure claims meet global regulatory requirements.

Design and deliver training sessions for key stakeholders on the new claims process.

Qualifications :

Preferred Skills :