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Sr. Quality Engineer - NxStage


Lawrence, Massachusetts

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Job ID JR0004991

PURPOSE AND SCOPE:

The incumbent applies systems engineering and quality assurance principles and techniques to the equipment product development and postmarket lifecycles.

PRINCIPAL DUTIES AND RESPONSIBILITIES:

  • Develops and establishes quality systems programs and plans that ensure compliance with the Quality System Regulations and ISO standards.
  • Perform risk analysis to identify appropriate protective measures to mitigate risk associated with identified hazards.
  • Review and update existing risk management documents based on postmarket data.
  • Track and trend complaint, service, and other postmarket data to drive risk assessments and product and process improvements.
  • Develop, execute, monitor, review, and report on CAPA plans related to sustaining engineering activities.
  • 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.
  • Develop and implement instructions and methods for inspecting, testing and evaluating product conformance to specification.
  • Maintain quality system information databases as assigned. Evaluate quality data and prepare periodic reports to monitor trends.
  • Complete activities associated with the formal release of product to finished goods
  • Conduct internal audits for evaluation of compliance with the Quality System Regulations.
  • Generate, review, and approve ECO’s and DCO’s for Quality Assurance.
  • Support Engineering in the development, testing, verification, validation and commercialization of new products.

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

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.

Ability to lift up to 50 lbs. as required.

The employee may also be exposed to bovine and human blood products. Hepatitis B Vaccination is recommended.

EDUCATION:

  • B.S. in Engineering Related Field
  • M.S. in Engineering Related Field Preferred

EXPERIENCE AND REQUIRED SKILLS:

  • 5+ years related quality engineering experience or an equivalent combination of experience and education. Medical device experience preferred.
  • Solid experience and aptitude for reliability engineering and risk management
  • ASQ CQE or CRE certification a plus.
  • Advanced working knowledge of FDA Quality System Regulation 21 CFR Part 820.
  • Good organizational, attention to detail and follow-through skills
  • Excellent verbal communication and customer interface skills.
  • Ability to interface with multiple groups in the organization.
  • Basic computer skills – word processing, spreadsheet, windows. MS Office preferred.
  • Willingness to contribute to other departments as necessary

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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