Senior Quality Engineer

1 month ago

Hamilton, United States FX Staffing Full time

Senior Engineer, Quality

Required:

  • Bachelor degree in Engineering discipline from an accredited university
  • A minimum of 6 years of relevant experience; OR master’s degree in related field plus 4 years’ experience

Preferred:

  • ASQ Certified Quality Engineer (CQE), ASQ Certified Reliability Engineer (CRE), Six Sigma Yellow/Green/Black Belts, and/or other similar certifications.
  • Quality Engineering Experience

Skills & Competencies:

  • Knowledge of Risk Management, device manufacturing, and statistical analysis techniques including use of Minitab (or comparable) software.
  • Possess a good balance of basic technical expertise, analytical thinking, and communication skills for resolving issues internal and external to the organization.
  • Word processing, spreadsheet and statistical analysis software packages (preferably Word, Excel and Minitab).

RESPONSIBILITIES:

  • Ensure product quality targets are achieved by supporting the design and implementation of test plans
  • Provide the design team with statistical guidance including sample size selection, test method validation strategies, and defining evidential requirements to support risk-management claims and mitigations
  • Guide the identification and traceability of requirements from Feasibility through Design Release. Ensure platform requirements are defined, verifiable, and are not redundant
  • Sponsor a robust execution of Risk Management activities throughout all phases of development and assurance the identified risks have been reduced as far as possible
  • Ensure that requirements are appropriately defined and tested and that the stress-conditions appropriately challenge the design to insure regulatory and pharma-partner needs are satisfied by the assigned subsystems
  • Guide various process and product development activities through sample-size determination, distribution identification and data analysis; and other means such as the selection, support and appraisal of inspection plans and process controls
  • Provide analysis and evaluations to support investigations, bounding, root-cause investigation and corrective actions per the corrective and preventative action program
  • Incorporate assessments of operational performance, product quality and the effectiveness of corrective actions into the risk-management documentation for the platform
  • Proactively communicate project risks and status to management and external partners as needed
  • Manage other job functions and duties; and provide for other product development projects, teams and activities as required
  • Provides project status to leadership

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