“This Company requires all staff, staff augmentation external workers, and certain other external workers, in the United States and puerto rico vaccinated from COVID 19 as a condition of assignment at this company. In accordance with applicable law, this company will provide reasonable accommodations staff augmentation external workers qualify on the basis of a medical reason or a sincerely held religious belief, practice, or observance. Such accommodation may not pose an undue hardship this company, its operations, or its staff.”
                                                            
Top 3 Must Have Skills

• MUST have experience with root cause analysis and technical investigation
• Compliant experience (similar industry preferred)
• Good oral and written communications skills
• Detail oriented
• Technical degree

Day to Day Responsibilities:
Responsibilities:

• Lead root cause analysis of mechanical and/or electromechanical products to identify root cause using tools such as tolerance analysis, fishbone diagrams, “5 Whys”, and risk assessments such as FMEA’s or Fault Tree Analysis
• Perform trend and consolidated investigations. Accountable for validity of statistical assessment of data to identify trends, as well as ownership of monthly reports
• Perform technical trend and consolidated investigations, including statistical assessment of data to identify trends, as well as generation of monthly reports
• Develop and perform relational data analytics in support of investigations
• Deliver reports and investigations on time per Amgen and regulatory requirements
• 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
• 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

"This posting is for Contingent Worker, not an FTE"