Sr. Quality Engineer Complaints Business Performance

Cambridge, MA, US
Oct 29, 2020
Required Education
High School or equivalent
Position Type
Full time
Job Summary

Amgen is seeking a Senior Quality Engineer and member of the Product Complaints and Surveillance team. The Product Complaints and Surveillance team owns and executes the end-to-end global complaint process and management system, ensuring appropriate business connection across Amgen. In doing so, the focus is on assuring complaint processes and systems remain fully compliant through the quality operating standards and procedures to current, emerging internal and external requirements. In addition, the team translates information from the market to drive continuous improvement.

The Sr. Quality Engineer finds ways to prevent waste and inefficiency in processes by designing efficient systems that integrate and assist in the prioritization and scheduling of workloads, identifying process improvements, and ensuring teams are managing daily activities most effectively. This role will also design processes to coordinate workload planning to minimize complaint processing issues and ensure complaint records are closed in a timely manner with the highest of quality standards.

Key Responsibilities:
  • Reviews process information to understand methods and activities in the complaints and surveillance organization. This includes, but is not limited to, schedules, process flows and workflows.
  • Designs systems to minimize and resolve processing issues and increase productivity.
  • Plans daily workload management to ensure all records and samples are processed in a timely manner
  • Develops processes to ensure productivity and efficiencies
  • Conducts daily stand-up meeting to ensure efforts are coordinated in an effective manner across working teams
  • Designs, develops and maintains processing and oversight practices to maximize effectiveness, efficiency and space
  • Designs and implements capacity models to drive proactive planning and efficiency across the organization
  • Ensures the organization complies with all standards for safety, quality, and compliance
  • Works in a support role as needed on less complex projects

Basic Qualifications

Doctorate degree


Master's degree and 3 years of Quality / Manufacturing experience


Bachelor's degree and 5 years of Quality / Manufacturing experience


Associate's degree and 10 years of Quality / Manufacturing experience


High school diploma / GED and 12 years of Quality / Manufacturing experience

Preferred Qualifications
  • 4+ years of Industrial Engineering, quality and/or manufacturing experience in a related industry (i.e., Biotech, Pharmaceutical, Automotive)
  • Industrial Engineering Degree
  • In-depth knowledge of planning, prioritization, and scheduling tools
  • Knowledge of current Global regulations and their application
  • Understanding of Investigations and Root Cause Analysis
  • Understanding of the criticality of aligning target timeline and driving process improvements
  • Experience in planning, coordinating, and managing large throughput operations
  • Detail-oriented with experience in QA/QC functions across a broad range of manufacturing, QC and/or supply chain processes
  • Ability to work in a team matrix environment and independently interact with various levels of management
  • Good communication skills, both written and oral
  • Ability to create cross-functional networks/partnerships
  • Ability to plan, monitor, and control a set of activities, ensuring efficient utilization of resources to achieve program objectives
  • A passion for managing for daily improvement
  • Indirect leadership skills and the ability to oversee multiple projects simultaneously
  • Able to successfully and independently manage workload, timelines, and priorities
  • Familiarity with advanced project management tools
  • Ability to operate in a matrixed or team environment with site, functional, and executive leadership
  • Ability to travel +/- 20% of time to domestic and international Amgen sites

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.

Amgen focuses on areas of high unmet medical need and leverages its expertise to strive for solutions that improve health outcomes and dramatically improve people's lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world's leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential.

Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.

Join Us

If you're seeking a career where you can truly make a difference in the lives of others, a career where you can work at the absolute forefront of biotechnology with the top minds in the field, you'll find it at Amgen.

Amgen, a biotechnology pioneer, discovers, develops and delivers innovative human therapeutics. Our medicines have helped millions of patients in the fight against cancer, kidney disease, rheumatoid arthritis and other serious illnesses.

As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other but compete intensely to win. Together, we live the Amgen values as we continue advancing science to serve patients.

Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.