Senior Engineer, Complaints & Root-Cause Analytics

BioSpace; Thousand Oaks (CA); On-site; USD 120,000 - 180,000; Full time

Benefits offered by this job

Competitive benefits

Flexible work models where possible

Job summary

Amgen is seeking a Senior Engineer - Complaints Technical Investigator to join the Complaints Technical Investigations group. You will conduct advanced investigations of product complaints, own CAPAs, and drive cross-functional design improvements to enhance patient experience and product quality.

You will interact with engineering and quality functions, perform trend analyses, and mentor staff while contributing to robust investigation plans and reports that support regulatory and safety

Qualifications

• Doctorate degree OR
• Masters degree and 2 years of operations experience OR
• Bachelors degree and 4 years of operations experience OR
• Associates degree and 8 years of operations experience OR
• High school diploma / GED and 10 years ofoperations experience

Responsibilities

• Lead root cause analysis to identify the failure mode for Amgens products and associated components due to product complaint
• Perform failure analysis to identify root cause using processes and tools such as fishbone diagrams, 5 Whys, risk assessments such as FMEAs, Fault Tree Analysis, or tolerance analysis.
• Lead cross functional ideation of design solutions to reduce complaints based on output of root cause analysis, determine feasibility of options through testing and analysis, develop business plans for implementation
• Perform technical trends and consolidated investigations, including statistical assessment of data to identify trends
• Support the evaluation of returned products, product reserve sample inspections, batch records and review of complaint history and trends
• Generate final investigation reports in accordance with established procedures, which may include data collection and statistical analysis of the data
• Develop and perform relational data analytics in support of investigations
• Advise management for trend and failure investigation process improvement
• Provide input to engineering for product improvements
• Manage, coach and mentor staff
• Support functional management initiatives and objectives

Skills

Root cause analysis

FMEA

Six Sigma

Data analytics

Technical writing

Leadership

Cross-functional collaboration

Education

PhD in a science field

Master's degree + 2 years experience

Bachelor's degree + 4 years experience

Associate degree + 8 years experience

High school diploma + 10 years experience

Tools

Fishbone diagrams

5 Whys

Risk assessments

DFMEA/FMEA

Statistical analysis

CAPA processes

Job description

Amgen is seeking a Senior Engineer - Complaints Technical Investigator to join the Complaints Technical Investigations group. You will conduct advanced investigations of product complaints, own CAPAs, and drive cross-functional design improvements to enhance patient experience and product quality.

You will interact with engineering and quality functions, perform trend analyses, and mentor staff while contributing to robust investigation plans and reports that support regulatory and safety