Location
Bengaluru, KARNATAKA, India, India
Posted on
Apr 20, 2020
Profile
nGeneral Requirements: Quality Engineer in the Life Science Product Development ( Specially in the LD and POC diagnostics area )n nThis position is responsible to provide direction in the areas of Design Controls & Risk Management to cross-functional teams responsible for new product development or design changes. As a Subject Matter Expert (SME), the individual must be able to lead improvement projects and training on any of the elements within Design Controls.n n• Leads effective deployment of Quality Engineering tools for the effective and efficient development, transfer, and maintenance of products/processes throughout the product lifecycle. n• Serves as Subject Matter Expert for application of Design Controls in accordance to regulatory expectationsn• Drives and Provides guidance, recommendations, and expectations related to Design Control, Risk Management, Quality Engineering (e.g., Quality System Regulation, EU IVDD, ISO standards, etc.)n• Ensure the comprehensive completion of Design Verification, and Design Validation activities for productsn• Ensure the development and validation of appropriate test methods for product performancen• Ensure active and thorough investigation of quality issues and effective corrective and/or preventive actionn• Effectively utilizes Lean and Six Sigma methodologies as appropriate to achieve optimal resultsn n nEducation:n nMasters degree or higher in a Life Science, Engineering, or Physical SciencenCertifications, Licenses, Registrations:n nCertified Quality Engineer (ASQ CQE, CRE or equivalent) preferrednGreen Belt or Black Belt certification preferrednKnowledge and Experience:n nDemonstrated comprehensive knowledge of field of specialization to support the successful completion of complex assignments. This includes in-depth knowledge of ISO 13485, and FDA Quality System Regulations. Typically, 8-10 years of successful experience in related field and successful demonstration of Key Responsibilities.nDirection of Others:nThis is an individual contributor role. Provides specialized direction to professional counterparts on teams. Leadership qualities and role model qualities demonstrated.n nKey Working Relationships:nWill work with teams in the US.nWill need flexibility in working hoursnOrganization: Siemens HealthineersCompany: **MEMBERS ONLY**SIGN UP NOW***.Experience Level: Experienced ProfessionalJob Type: Full-time,qualifications:UNAVAILABLE,responsibilities:UNAVAILABLE,skills:UNAVAILABLE,workHours:UNAVAILABLE,jobBenefits:UNAVAILABLE,datePosted:2020-04-21T00:00:00 0000,employmentType:UNAVAILABLE,educationRequirements:UNAVAILABLE,salaryCurrency:USD,baseSalary:{@type:MonetaryAmount,currency:USD,value:{@type:QuantitativeValue,value:0,minValue:0,maxValue:0,unitText:YEAR}},validThrough:2021-04-21T06:23:28.000Z,industry:UNAVAILABLE,hiringOrganization:{@type:Organization,name:Siemens,sameAs:****
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