2 jobs found in monroeville, pennsylvania

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    • monroeville, pennsylvania
    • contract
    • US$1.00 - US$45.00, per hour, $1 - 45 per hour
    • 8am to 5pm
    job summary:Randstad is looking to hire a Design Quality Engineer for a client of ours in the Medical Device Industry. This position is 100% remote 6 month long contract (potential to extend longer). The person in this position will provide risk management and design control guidance for design quality assurance activities on medical device projects, and coordinate quality activities with engineering, clinical, sourcing, and manufacturing, distribution, service, and support teams. You will support the worldwide regulatory requirements through product submission, registration and continued compliance through complete life cycle of medical devices. This person will also provide regulatory and quality input for medical device products from generation through release to obsolescence assisting in planning, developing and quality support in projects. Skills RequiredWorking in disciplined, regulated industries. Medical device experience preferred.Expertise in FDA's 21 CFR 820/ISO 13485/14971/62304 standardsFamiliarity with IEC 60601 series of Medical Equipment Safety Standards.Familiarity with Problem solving, Investigations, Root Cause Analysis, Data analysis, Six-Sigma, Process control, failure modes effect analysis (FMEA) and other quality tools and techniques.Basic knowledge of Medical device International regulatory requirementsProactive engagement in finding and solving problems or preventing problemTeaming experience with positive outcomes location: Monroeville, Pennsylvaniajob type: Contractsalary: $1 - 45 per hourwork hours: 8am to 5pmeducation: Bachelors responsibilities:Ensure that projects to develop medical devices follow applicable company policies,procedures, standards and regulations.Ensure that released devices are safe and effective and meet their intended use.Manage safety risks associated with medical devices in accordance with IEC 14971:2012.Manage post-release safety risks associated with complaints and returns.Facilitate usability analysis and activities in accordance with IEC 62366.Represent QA on product defect review boards, and change control boards.Help coach project teams on use of quality system.Prepare for and participate in project and quality systems audits and inspections.Facilitate analysis and activities associated with corporate privacy and security proceduresProactively participate in design reviews, quality business reviews and post market improvement teams.Support the worldwide regulatory requirements through product submission, registration and continued compliance through complete life cycle of medical devices.Assist in investigating and reporting the results of investigations for reported technical problems as part of corrective actions qualifications:Experience level: Education: Bachelors skills: QualityEqual Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.
    job summary:Randstad is looking to hire a Design Quality Engineer for a client of ours in the Medical Device Industry. This position is 100% remote 6 month long contract (potential to extend longer). The person in this position will provide risk management and design control guidance for design quality assurance activities on medical device projects, and coordinate quality activities with engineering, clinical, sourcing, and manufacturing, distribution, service, and support teams. You will support the worldwide regulatory requirements through product submission, registration and continued compliance through complete life cycle of medical devices. This person will also provide regulatory and quality input for medical device products from generation through release to obsolescence assisting in planning, developing and quality support in projects. Skills RequiredWorking in disciplined, regulated industries. Medical device experience preferred.Expertise in FDA's 21 CFR 820/ISO 13485/14971/62304 standardsFamiliarity with IEC 60601 series of Medical Equipment Safety Standards.Familiarity with Problem solving, Investigations, Root Cause Analysis, Data analysis, Six-Sigma, Process control, failure modes effect analysis (FMEA) and other quality tools and techniques.Basic knowledge of Medical device International regulatory requirementsProactive engagement in finding and solving problems or preventing problemTeaming experience with positive outcomes location: Monroeville, Pennsylvaniajob type: Contractsalary: $1 - 45 per hourwork hours: 8am to 5pmeducation: Bachelors responsibilities:Ensure that projects to develop medical devices follow applicable company policies,procedures, standards and regulations.Ensure that released devices are safe and effective and meet their intended use.Manage safety risks associated with medical devices in accordance with IEC 14971:2012.Manage post-release safety risks associated with complaints and returns.Facilitate usability analysis and activities in accordance with IEC 62366.Represent QA on product defect review boards, and change control boards.Help coach project teams on use of quality system.Prepare for and participate in project and quality systems audits and inspections.Facilitate analysis and activities associated with corporate privacy and security proceduresProactively participate in design reviews, quality business reviews and post market improvement teams.Support the worldwide regulatory requirements through product submission, registration and continued compliance through complete life cycle of medical devices.Assist in investigating and reporting the results of investigations for reported technical problems as part of corrective actions qualifications:Experience level: Education: Bachelors skills: QualityEqual Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.
    • monroeville, pennsylvania
    • contract
    • US$17.00 - US$22.00, per hour, $17 - 22 per hour
    • 8am to 5pm
    job summary:Immediate Need || Hands on Desktop II Monroeville, PA II Resume to Hire *At least 3 solid RECENT years of HANDS-ON, DESK-SIDE DESKTOP support experience. NOT PHONE/EMAIL/REMOTE *LARGE enterprise experience supporting large amount of users. *Windows 7 and 10 - recently migrated to Win10 *A+ cert and/or Microsoft cert - REQUIREDPay rate :27$/hrIf you are interested, Kindly share your updated resume @laxmib.singh@randstadusa.com. so I can call you to discuss this opportunity in detail.  location: Monroeville, Pennsylvaniajob type: Contractsalary: $17 - 22 per hourwork hours: 8am to 5pmeducation: Bachelors responsibilities:na qualifications:Experience level: ExperiencedEducation: Bachelors skills: Desktop SupportImagesEqual Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.
    job summary:Immediate Need || Hands on Desktop II Monroeville, PA II Resume to Hire *At least 3 solid RECENT years of HANDS-ON, DESK-SIDE DESKTOP support experience. NOT PHONE/EMAIL/REMOTE *LARGE enterprise experience supporting large amount of users. *Windows 7 and 10 - recently migrated to Win10 *A+ cert and/or Microsoft cert - REQUIREDPay rate :27$/hrIf you are interested, Kindly share your updated resume @laxmib.singh@randstadusa.com. so I can call you to discuss this opportunity in detail.  location: Monroeville, Pennsylvaniajob type: Contractsalary: $17 - 22 per hourwork hours: 8am to 5pmeducation: Bachelors responsibilities:na qualifications:Experience level: ExperiencedEducation: Bachelors skills: Desktop SupportImagesEqual Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.

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