Job Title: Quality Systems Engineer

Job Description

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 strong experience 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. Additionally, the role involves collecting and reviewing existing documentation to identify and substantiate claims, and training key stakeholders on the newly developed claims process.

Responsibilities

• Collect and review existing internal documentation to identify potential marketing claims.
• Organize and document findings to support traceability and validation efforts with the 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.
• Assess claims made for different user populations to ensure appropriate substantiation.
• Utilize Pepper Flow software to manage and maintain traceability of claims to source documentation.
• Ensure all documentation is audit-ready and compliant with internal and external quality standards.
• Develop, implement, and maintain Standard Operating Procedures (SOPs) for the creation, review, and approval of marketing claims.
• Collaborate with cross-functional teams to align SOPs with business and compliance needs.
• Partner with Regulatory Affairs to ensure claims meet global regulatory requirements.
• Work closely with Engineering and Clinical teams to gather and interpret data supporting claims.
• Provide training and guidance to internal stakeholders on claim substantiation processes.
• Design and deliver training sessions for key stakeholders on the new claims process.
• Ensure consistent understanding and adoption of the process across relevant departments.

Essential Skills

• Bachelor’s degree in Engineering, Life Sciences, or related field (Master’s preferred).
• 8–10 years of experience in Quality Systems or Regulatory Affairs within the medical device industry.
• Strong understanding of FDA regulations and other relevant standards.
• Experience with Pepper Flow or similar document control/traceability systems.
• Demonstrated ability to critically evaluate scientific and engineering data.
• Excellent written and verbal communication skills.
• Strong organizational and project management skills.

Additional Skills & Qualifications

• Familiarity with global regulatory environments (e.g., EU MDR, Health Canada).
• Prior experience developing SOPs and quality documentation.
• Knowledge of human factors and usability engineering as it relates to different user populations.

Work Environment

This position is onsite in Irvine, CA. The work environment is collaborative, involving cross-functional teams including Marketing, R&D, Regulatory, and Clinical departments. Employees enjoy 2 weeks of PTO and 10 client-paid holidays.