• FRESENIUS
  • $94,360.00 -141,170.00/year*
  • Jamaica Plain , MA
  • Engineering
  • Full-Time
  • 7 Greenough Ave

PURPOSE AND SCOPE:

The incumbent is responsible for supporting design and sustaining quality related to fluid products manufactured by NxStage and its suppliers including but not limited to Corrective and Preventive Actions, Supplier Quality, Quality Data and Trending, and other select quality systems.

PRINCIPAL DUTIES AND RESPONSIBILITIES:

Responsibilities:

Lead major efforts, or phases of projects, to resolve advanced and complex technical and Quality-related problems

Support the product development teams in the adoption and use of best practices, Quality tools, and Design Control methodologies

Provide Design assurance and New product development support on fluid projects

Support manufacturing site with process validation and verification activities

Perform Risk Analysis including, Fault Tree Analysis (FTA), Human Factors/Usability files, and Failure Mode and Effects Analysis (FMEA) activities to ensure process shortcomings are identified and appropriately addressed

Lead/support Risk Management activities to ensure design and process shortcomings are identified and appropriately addressed

Monitoring and developing reliability improvements to existing & new design

Support the investigation into the feasibility of new projects, systems or approaches

Work with other Groups to maintain an approved internal Quality System that meets the requirements of GMP s, QSR and ISO

Maintain quality system information databases as assigned. Evaluate quality data and prepare periodic reports to monitor trends

Generate, review and approve ECO s and DCO s for Quality Assurance

Evaluate quality data and prepare periodic reports to monitor trends

Process non-conforming material reports including MRB dispositioning

Complete activities associated with the formal release of product to finished goods

Participate in external and internal audits such as FDA, Notified Body and corporate

Develop and implement instructions/methods for inspecting, testing and evaluating product conformance to specification. Specific to Fluids and their ingredients

Support manufacturing in the investigation of manufacturing problems and product complaints to determine the root cause and recommend appropriate corrective and preventive action to prevent recurrence..

Provide guidance and direction to the Quality functions at the various manufacturing facilities which will include supporting CAPA, MRB decisions, Change Control (ECO/DCO),

Participate in the development of new processes and products, issue resolution, design reviews and design transfer

Responsible for continuous improvement in product quality assessments based on statistical methods used in the inspection of product and the trending of quality data using industry standard Quality tools

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

    7+ years of experience in medical device or pharmaceutical fluid fabrication and packaging, LVP solution experience preferred

    ASQ certification a plus

    FDA experience in medical device and parenteral drug industry preferred

    Intermediate knowledge of FDA Medical Device Regulations including Quality System Regulation 21 CFR Part 820, and applicable international quality standards including ISO 13485:2003, Canadian MDR, Medical Device Directive, and ISO14791

    Strong analytical skills, excellent verbal communication and customer interface skills

    Ability to interface with multiple groups in the organization


    Associated topics: bio, biochemistry, bioengineering, biomaterials, biomechanics, biomedical engineer, enzyme, medical, neuro, parenteral

    * 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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