• FRESENIUS
  • $96,010.00 -138,950.00/year*
  • Revere , MA
  • Engineering
  • Full-Time
  • 69 Rose St

PURPOSE AND SCOPE:

The incumbent is responsiblefor supporting design and sustainingquality related to fluid products manufactured by NxStage and its suppliersincluding but not limited to Corrective and Preventive Actions, SupplierQuality, Quality Data and Trending, and other select quality systems.

PRINCIPAL DUTIES AND RESPONSIBILITIES:

Provide QualityEngineering support for sustaining and development projects

Supportmanufacturing in the investigation of manufacturing problems and productcomplaints to determine the root cause and recommend appropriate corrective andpreventive action to prevent recurrence

Support the investigationinto the feasibility of new projects, systems or approaches

Perform Risk Analysis including, Fault Tree Analysis (FTA), HumanFactors/Usability files, and Failure Mode and Effects Analysis (FMEA)activities to ensure process shortcomings are identified and appropriatelyaddressed
Lead/support Risk Management activities to ensure design and processshortcomings are identified and appropriately addressed
Monitoring and developing reliability improvements to existing & newdesign
Maintain quality system information databases as assigned. Evaluate qualitydata and prepare periodic reports to monitor trends
Generate, review and approve ECO s and DCO s for Quality Assurance
Process non-conforming material reports including MRB dispositioning
Complete activities associated with the formal release of product to finishedgoods
Develop and implement instructions/methods for inspecting, testing andevaluating product conformance to specification. Specific to Fluids and theiringredients
Provide guidance and direction to the Quality functions at the variousmanufacturing facilities which will include supporting CAPA, MRB decisions,Change Control (ECO/DCO),
Responsible for continuous improvement in product quality assessments based onstatistical methods used in the inspection of product and the trending ofquality data using industry standard Quality tools

Perform Quality controlinspection of the Certificate of Analysis of each lot supplied by the contractmanufacturer and provide QC release for products

Additional responsibilities may include focus on one or more departments or locations. See applicable addendum for department or location specific functions.

Qualifications

PHYSICAL DEMANDS AND WORKING CONDITIONS:

  • The physical demands and work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions
  • Education & Qualifications:

    BS/BA in Science, Chemistry or Microbiology preferred
    2+ years of experience in medical device or pharmaceutical fluid fabricationand packaging, LVP solution experience preferred
    Intermediate knowledge of FDA Medical Device Regulations including QualitySystem Regulation 21 CFR Part 820, and applicable international qualitystandards including ISO 13485:2003, Canadian MDR, Medical Device Directive, andISO14791
    Strong analytical skills, excellent verbal communication and customerinterface skills

    Job

    :Research and Development

    Primary Location

    :United States-Massachusetts-Lawrence

    Schedule

    :Full-time

    Shift

    :Day Job::-
    Associated topics: aerodynamic, assembly, autocad, catia, design, machine, mechanical engineer, naval, propulsion, turbine

    * The salary listed in the header is an estimate based on salary data for similar jobs in the same area. Salary or compensation data found in the job description is accurate.

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