Quality Complaints Investigation Engineer

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

• Able to collaborate and communicate with cross functional team
• Experience in technical investigation and root cause analysis

Note:

Onsite 80%, must be available to go onsite when needed - Hybrid

Expectation is that they will need to be onsite.

Preferably Local candidates

Work Schedule: Dayshift

The complaints investigation technical investigator will perform the device assessment of complaint samples using lab equipment such as the CT scanner and Instron testing machines. S/he will be responsible for authoring the assessment report and communicating the findings and results to management and cross-functional team as required. S/he will be responsible for the validity and integrity of the evaluation reports. The Technical Investigator will maintain close interaction with the quality complaints owner. Additional responsibilities include supporting investigations by performing characterization testing, data gathering and analysis, as well as supporting/leading root cause analysis.

S/he will also support the implementation, validation, and operation of the equipment in the lab, providing personnel training on the use of the equipment, developing and updating equipment procedures, participating in the monthly lab safety inspection, and identifying and reporting equipment repairs or maintenance. S/he will work with the vendor to resolve issues and suggest improvements associated with the operation of the equipment.

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

Basic 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.

Preferred Qualifications

• 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 execution, and writing standard operating procedures (SOP)
• Strong technical writing and interpersonal skills
• Results-driven and detail-oriented
• Strong Sense of Responsibility and Time Management.
• Demonstrated competency in root cause analysis methodology

Basic Qualifications

Master degree OR Bachelor degree and 2 years of experience OR Associate degree and 6 years of experience OR High school diploma / GED and 8 years of experience