Complaints Investigation Technical Investigator
Company: Aditi Consulting
Location: Thousand Oaks
Posted on: June 25, 2022
Job Description:
Job Title: Complaints Investigation Technical
InvestigatorLocation: Thousand Oaks, CADuration: 1+ Year Contract
(Potential to extend) Description: Must be fully
vaccinatedOnsiteM-F stand operation
- client 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 client's mission to serve
patients, the Complaints Trending and Investigation group at client
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 client and
regulatory requirements
- Understand customer / patient use of client's packaged and/or
distributed mechanical and/or electromechanical products
- Understand manufacturing processes for client'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 Top 3 Must Have Skill Sets:
- 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 client and
regulatory requirements
- Understand customer / patient use of client's packaged and/or
distributed mechanical and/or electromechanical products
- Understand manufacturing processes for client'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
Keywords: Aditi Consulting, Thousand Oaks , Complaints Investigation Technical Investigator, IT / Software / Systems , Thousand Oaks, California
Didn't find what you're looking for? Search again!
Loading more jobs...