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Complaints Investigation Technical Investigator

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

Top 3 Must Have Skill Sets:                        
  • Good oral and written communications skills
  • Detail oriented
  • Technical degree
Day 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 this company and regulatory requirements
  • Understand customer / patient use of this company’s packaged and/or distributed mechanical and/or electromechanical products
  • Understand manufacturing processes for this company’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
Summary
This company is currently seeking a complaints investigation technical investigator in our Complaints Trending and Investigation group. This position will report to our Sr. Manager of Complaints Trending and Investigation. In support of this company’s mission to serve patients, the Complaints Trending and Investigation group at this company is 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 complaints investigation technical investigator will conduct technical investigations of Level 2 and 3 complaints associated with product design and/or usability issues, as well as conduct trend and consolidated investigations using data analytics. S/he will be responsible for the validity and integrity of the investigations and reports, including the data and its statistical analysis. S/he will also participate and/or lead in cross functional ideation of design solutions. The complaints investigation technical investigator maintains close interaction with the engineering and quality management functions to contribute to product improvement and management reporting. Additionally, s/he will support the implementation and validation of the equipment in the investigation lab.
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 this company and regulatory requirements
Understand customer / patient use of this company’s packaged and/or distributed mechanical and/or electromechanical products
Understand manufacturing processes for this company’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

Basic Qualifications
Master’s degree and 3 years of related medical/biopharma development or Operations experience; OR
Bachelor’s degree and 5 years of related medical/biopharma development or Operations experience; OR
Associate’s degree and 8 years of related medical/biopharma development or Operations experience;
Preferred Qualifications
  • Bachelor’s, Master’s or PhD in Engineering, Science or Biomedical
  • 2+ years of experience in complaints investigation within a development, manufacturing, post-market or equivalent environment
  • Experience with statistics and statistical analysis
  • Demonstrated competency in root cause analysis methodology
  • Experience with protocol and report writing, process and test development and execution, and writing standard operating procedures (SOP)
  • Strong technical writing and interpersonal skills
  • Results-driven and detail-oriented team leader

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

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