Quality Complaints Investigator & Lab RCA Engineer (Onsite)

ACL Digital; Thousand Oaks (CA); Hybrid; USD 85,000 - 120,000; Full time

Job summary

Amgen in Thousand Oaks, CA is seeking a Technical Investigator to perform device assessments of complaint samples using lab equipment, authoring assessment reports, and communicating findings to management and cross-functional teams. Role focuses on ensuring validity of evaluation reports and close collaboration with quality complaints owners.

The candidate will support investigations with characterization testing, data gathering, root cause analysis, and contribute to lab equipment validation,

Qualifications

• Bachelor’s degree and 2 years of related medical/biopharma development or Operations experience; OR
• Associate degree and 6 years of related medical/biopharma development or Operations experience.
• Master’s or Bachelor’s in Engineering, Science or Biomedical
• 2+ years of experience in complaints investigation within a development, manufacturing, post-market or equivalent environment
• Experience in lab environment
• Experience with assessment writing, process and test development and writing standard operating procedures (SOP)
• Strong technical writing and interpersonal skills
• Results-driven and detail-oriented
• Demonstrated competency in root cause analysis methodology

Responsibilities

• Perform device assessments of complaints and document results in a report.
• Complete evaluation and deliver assessment report on time per Amgen requirements.
• Support the implementation and management of the lab infrastructure, including all equipment used for investigations
• Provide requirements for lab and investigational equipment to device development teams in support of new device platforms
• Support characterization testing and data gathering for investigations
• Perform root cause analysis investigations for mechanical and/or electromechanical products

Skills

Cross-functional collaboration

Root cause analysis

Technical investigation

Technical writing

Education

Bachelor’s degree in Engineering/Science/Biomedical

Associate degree

Master’s or Bachelor's in Engineering/Science/Biomedical

Tools

CT scanner

Instron testing machines

Job description

Amgen in Thousand Oaks, CA is seeking a Technical Investigator to perform device assessments of complaint samples using lab equipment, authoring assessment reports, and communicating findings to management and cross-functional teams. Role focuses on ensuring validity of evaluation reports and close collaboration with quality complaints owners.

The candidate will support investigations with characterization testing, data gathering, root cause analysis, and contribute to lab equipment validation,