Quality Assurance Engineer

Mednet Healthcare Technologies   •  

Rochester, NY

Industry: Pharmaceuticals & Biotech


5 - 7 years

Posted 170 days ago

This job is no longer available.

The Quality Assurance Engineer isresponsible for ensuring compliance and forinternal processesassociated with the Quality System and quality assurance

as part of regulatory compliance requirements and governed by the BioTelemetry
Research Quality System Procedures.




§  Performingfinalproductdeliveryreviewonexternalfacingcustomerdeliverables

§  SupportingCorporateSupplierManagementactivityrelatedtoclinical trial studies:audits,approvedsupplier process,inventoryandsourceinspection

§  Managingthe Corrective Actionprocess,includingcustomercomplaints

§  Monitoring and reportingperformancesandQualitymetricsmonthly

§  SupportingtheDeviation,Letter-to-FileandAudit(Internal&External)processes


§  Bachelor’sdegreeinEngineering,LifeScienceorequivalent


§  Five (5)yearsexperienceinQualityor Regulatoryenvironment

§  DemonstratedknowledgeofGoodClinicalPractices,GXPs,as wellasglobalregulations

§  Experienceinclinicaltrials,medicaldeviceand/orpharmaceutical  industrypreferred


§  Mastering Good Documentation Practices

§  Highly developed investigational skills

§  Excellent understanding of 21 CFR Part 11 and other FDA regulatory requirements (especially those associated with clinical trials), GCP and ICH guidelines and directives

§  Ability to work with data spreadsheets, select metrics and identify trends

§  Strong written and verbal communication skills

§  Abilitytoworkingroupsandindividuallywithlittle supervision

§  Computer literacy and training and experience in Microsoft Office products, required