Job Description

WHAT YOU WILL DO

Let’s do this. Let’s change the world. In this vital role you will report to our Sr. Manager ISM Engineering. The Integrated Signal Management group within Global Patient Safety is responsible for the direction and strategy for the product safety signal detection and quality complaints trending program. In support of Amgen’s mission to serve patients, it drives the definition and implementation of innovation and standard methodologies for safety analytics, signal detection management, product complaints trending, and integrated product surveillance activities.

Understand customer / patient use of Amgen’s packaged and/or distributed mechanical and/or electromechanical products
Understand manufacturing processes for Amgen’s packaged and/or distributed products.
Perform product complaints statistical excursion trending deep dives and present data to support identification of potential quality signals requiring further investigation
Review product complaints, ongoing or past investigation results, product or process CAPA and deviation data
Maintain close interaction with multiple functions including Quality (e.g. complaints, device quality, product quality, external supplier quality, manufacturing quality, quality engineering) and contribute to product / device design improvements
Collaborate with other safety functions to support integrated surveillance of Amgen products from both quality and safety’s perspectives
Provide recommendations to management on process improvement opportunities

WIN

WHAT WE EXPECT OF YOU

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

Doctorate degree or
Master’s degree and 3years of relevant medical/biopharma development or post-market experience or
Bachelor’s degree and 5 years of relevant medical/biopharma development or post-market experience

PREFERRED QUALIFICATIONS

Degree in Engineering, Science or BioMedical;
4+ years of quality and/or manufacturing experience as an engineer in biotech or pharmaceutical industry
2+years of experience in complaints or complaints trending within a development, manufacturing or post-market environment, working with medical devices or combination products, ideally Class II and Class III
Experience with mechanical and/or electromechanical medical devices

THRIVE

SOME OF THE VAST REWARDS OF WORKING HERE

As we work to develop treatments that take care of others, so we 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 maximize 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