Senior Quality Engineer - Hamilton, United States - FX Staffing

Description

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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