QUALITY CONSULTING GROUP, a leader in the pharmaceutical, biotech, medical devices, and manufacturing industry, is looking for a talented, highly motivated and enthusiastic to join our team. In this role, you’ll work with a highly enthusiastic team, contributing in a world-class manufacturing industry in Puerto Rico & USA. Responsibilities: + Performs analyses, inspection, and Complaints DHR Review related with patients' complaints.  + Manage data analysis and investigate reasons for claims to determine and identified if patient risk associated with manufacture process.  + Analyze data to ensure quality standards and compliance to customer and regulatory requirements, and tolerance specifications for the chemical or physical property. + Specific Skills managing data systems. + Performs a variety of qualitative tests or qualitative assays on samples, and to aid in maintenance and certification of test instruments and apparatus to ensure compliance. + Performs required inspections, checks, analysis and documentation of studies. + Prepares and monitors quality statistics and reports. + Reviews production records for conformance to procedures. + Conducts non-conformance tests of manufactured, packaged or tested product. Qualifications: + Vocational or technical education or certification + Familiar with relevant quality regulations (21 CFR Part 820.30), Human factors/usability engineering standards (IEC 62366-1, ANSI HE75), risk management (ISO 14971), and FDA guidance. + Accurate and efficient data management + Complaint investigator + Analysis Risk + Requires minimum of 7 years of relevant experience + Document Control Specialist experience + Availability for 1st shift Quality Consulting Group, LLC is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity,, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law. Powered by JazzHR