Career Category

Job Description

HOW MIGHT YOU DEFY IMAGINATION?

You’ve earned your degree. How will you use that achievement to reach your goals? Do more with the knowledge you’ve worked hard to acquire and the passion you already have. At Amgen, our shared mission—to serve patients—drives all that we do. It is key to our becoming one of the world’s leading biotechnology companies, reaching over 10 million patients worldwide. Become the professional you are meant to be in this meaningful role.

Live

What you will do

Let’s do this. Let’s change the world.

Amgen is currently seeking a Sr. Complaints Technical Investigator in our Complaints Trending and Investigation group. In support of Amgen’s mission to serve patients, we are a diverse team working to continuously improve our clinical and commercial drug delivery devices in order to ensure supply and to optimize the patient experience.

The Sr. Complaints Technical Investigator conducts technical investigations, including root cause analysis, for complaints associated with product design and/ or usability issues and conducts trend and consolidated investigations using data analytics. This role understands customer/ patient use of Amgen’s packaged and/or distributed products, as well as manufacturing processes for these products. The Sr. Complaints Technical Investigator owns CAPA’s to support identifying design solutions based on root cause and will also participate in multi-functional ideation of design solutions. S/He also maintains close interaction with the engineering and quality functions to contribute to product improvement. Responsibilities also include evaluation of returned product using equipment such as CT scanners, support with investigation lab infrastructure, equipment setup, personnel training and method development and validation.

Job responsibilities:

• Lead root cause analysis to identify the failure mode for Amgen’s 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 FMEA’s, Fault Tree Analysis, or tolerance analysis. Additional equipment such as CT scanners, Instron tensile test machines and SEM may be used.

• Lead multi-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

• Lead technical trend and consolidated investigations, including statistical assessment of data to identify cause of trends

• Lead evaluation of returned product, product reserve sample inspections, batch records and review of complaint histories and trends

• Generate final 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 recommendations to engineering for product improvements

• Manage, coach and mentor staff

• Support functional management initiatives and objectives

• Help with investigations lab equipment setup, develop and provide equipment training to personnel, develop and validate test methods, and develop SOPs for equipment use.

Win

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The dynamic professional we seek is an employee with these qualifications.

Basic Qualifications

Doctorate degree

OR

Master’s degree and 3 years of Operations experience

Or

Bachelor’s degree and 5 years of Operations experience

Or

Associate’s degree and 10 years of Operations experience

Or

High school diploma / GED and 12 years of Operations experience

Preferred qualifications

• Master’s Degree in Science

• 10+ years of progressive and relevant experience

• 5+ years of experience in complaints or failure analysis investigation within a development or manufacturing environment, working with Medical Devices, ideally Class II and Class III

• Proven experience with medical devices

• Demonstrated Six Sigma proficiency specifically for root cause analysis methodology

• Experience with risk management per ISO 14971 (System Risk Analysis, User Risk Analysis, DFMEA/FMEA and other Risk Management tools)

• Experience with protocol and report writing, process and test development and execution, and design of experiments

• Experience in leading continuous improvement activities by driving the implementation of process and product quality improvement initiatives

• Strong technical writing and interpersonal skills

Thrive

Some of the vast rewards of working here

As we work to develop treatments that take care of others, we also work to care for our teammates’ professional and personal growth and well-being.

• Full support and career-development resources to expand your skills, enhance your expertise, and improve your potential along your career journey

• A diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act

• Generous Total Rewards Plan—comprising health, finance and wealth, work/life balance, and career benefits—with compensation and benefits rated above 4 stars (out of 5) on Glassdoor

Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology.

Apply now

for a career that defies imagination

Objects in your future are closer than they appear. Join us.

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