Job ID 20000DPC
Available Openings 1
Position Specific Information We are leveraging virtual technology to engage with you and keep us all safe while you explore a career with us. We will conduct all interviews virtually, to allow us to still connect about this job and proceed with our hiring process while practicing social distancing.
NxStage Medical, a Fresenius Company is on a mission to transform renal care. To do that, we continually seek the best-of-the-best to expand and improve our team of dedicated, innovative professionals.
As a key member of the Quality Team, the incumbent will support quality activities related to the design, development, and reliability of NxStage Medical's equipment products.
- Provide technical and statistical reliability support to Product Development, Manufacturing and Quality organizations
- Assist with major efforts, or phases of projects, to resolve advanced and complex technical and Quality-related problems
- Contribute to New Product Introduction Projects as a core team member and communicate activities to the extended team members of Quality
- Support the product development teams in the adoption and use of best practices, Quality tools, and Design Control methodologies
- Perform Risk Analysis including Fault Tree Analysis (FTA), Human Factors/Usability, and Failure Mode and Effects Analysis (FMEA) activities to ensure risks are identified and appropriately addressed
- Support Risk Management activities to ensure design and process shortcomings are identified and appropriately addressed
- Monitor and develop reliability improvements to existing & new designs
- Support Post Market Surveillance in the investigation of product complaints to determine the root cause and recommend appropriate corrective and preventive action to prevent recurrence
- Work with other Groups to maintain an approved internal Quality System that meets the requirements of GMP's, QSR 21 CFR Part 820 and ISO 13485
- Evaluate quality data and prepare periodic reports to monitor trends.
- Generate, review and approve Engineering and Development Change Orders for Design Assurance
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.
Bachelor's Degree in Engineering required
EXPERIENCE AND REQUIRED SKILLS:
- 3 years' related experience; or an advanced degree without experience; or equivalent directly related work experience
- ASQ Certification(s) and exposure to Six Sigma techniques a plus
- Knowledge of Design Validation and Design Verification tools and techniques
- Excellent verbal communication and technical writing skills
- Ability to interface with multiple groups in the organization Exposure to FDA Quality System Regulation 21 CFR Part 820 and ISO13485 required, in particular Design Control requirements
- Knowledge of risk management tools and techniques. FMEAs, FTAs, ISO 14971 risk management standard
EO/AA Employer: Minorities/Females/Veterans/Disability/Sexual Orientation/Gender Identity
Fresenius Medical Care North America maintains a drug-free workplace in accordance with applicable federal and state laws.
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