Complaints Investigator (Mechanical/Electromechanical)

Greetings from Ampcus!Ampcus Inc. is a Global leader in end-to-end IT Business Solutions and Services with latest technologies. We are listed among the top 50 fastest growing companies in USA. We work closely with our clients for Talent acquisition.Must Have Skill Sets: • Must have experience with root cause analysis and technical investigation• Compliant experience (similar industry preferred)• Good oral and written communications skills• Detail oriented• Technical degreeDescription: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 mission to serve patients, the Complaints Trending and Investigation group 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 regulatory requirements• Understand customer / patient use of packaged and/or distributed mechanical and/or electromechanical products• Understand manufacturing processes for 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 platformsBasic 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