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Thứ Tư, 25 tháng 2, 2015

Sr Quality Eng Software - Fresenius Medical Care - Waltham, MA

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Supports FMCNA’s mission, vision, core values and customer service philosophy. Adheres to the FMCNA Compliance Program, including following all regulatory and division/company policy requirements.

The main scope of this position is to ensure that FMCNA regulated computer systems are developed, validated, and maintained in compliance with corporate software validation lifecycle policies and procedures.


  • Responsible for driving the FMCNA culture through values and customer service standards.

  • Accountable for outstanding customer service to all external and internal customers.

  • Develops and maintains effective relationships through effective and timely communication.

  • Takes initiative and action to respond, resolve and follow up regarding customer service issues with all customers in a timely manner.


  • Represent the Quality Systems Department on software development teams as the software validation subject matter expert.

  • Partner with and/or lead Business Teams and IT to ensure that computerized quality systems are compliant with FMCNA procedures, FDA Quality System Regulations, 21 CFR Part 11 and GAMP5.

  • Lead and coordinate multiple software validation projects across FMCNA.

  • Create and/or oversee the creation of validation deliverables including but not limited to Validation Assessments, Validation Plans, Test Plans, Test Protocols, Test Reports, Validation Summary Reports and Trace Matrices, as needed to support local and enterprise system implementation in a regulated (FDA) environment. Lead the review and approval of validation deliverables.

  • Develop and create test protocols as necessary. Conduct independent reviews of test executions.

  • Lead Business Owners/teams and IT in the definition and creation of Business Requirements, Functional Specifications and System Specifications as necessary.

  • Compile, maintain and evolve approved project deliverables.

  • Communicate project and compliance issues to Quality Systems management and provide solutions to potential risks.

  • Develop and project manage Internal and External regulatory audits/ inspections by presenting and defending system validation projects and documentation during audits and FDA inspections as Subject Matter Expert.

  • Provide guidance/direction to external contractors working on system validation projects.

  • Ownership and responsibility that all pertinent validation deliverables are of high product quality and are compliant with the FMCNA policies and procedures.

  • Work with little to no supervision to fulfill duties in accordance with requirements of the QSR regulations, GAMP5, Corporate policies and procedures.

  • Follow all policies, guidelines, and SOP’s as required.

  • Complete other duties as assigned.


BS or higher degree in Computer Science, Software Engineering or related field required.


5 to 8 years’ experience in software engineering, information technology, or software quality assurance in a regulated environment.

· Thorough understanding of FDA Quality System regulations in relation to computer system validation

ASQ CSQE Certification or equivalent preferred.

Extensive experience with one or more of the following highly desirable: SAP, PTC, WindChill, Pilgrim.

Excellent verbal and written communication skills.

Excellent team work and interpersonal skills.

Experience with spreadsheet validation.

Very strong analytical and problem solving skills.

Excellent attention to detail, resourceful, self-reliant, self-motivated and confident.

EO/AA Employer: Minorities/Females/Veterans/Disabled


Fresenius Medical Care - 19 hours ago - save job

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