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Quality Engineer
Ref No.: 18-00070
Location: Canaan, Connecticut
Qualifications:
Education BA/BS Degree (Major: Mechanical or Manufacturing Engineering) Experience Minimum of six months experience working in a manufacturing environmentc

Responsibilities:
Develops solutions to routine problems of limited scope. Follows company procedures for areas of assigned responsibility. Limited knowledge of applicable regulatory, Corporate and/or Unit requirements Effective communicator; ensuring all complaints are acknowledged, investigated and completed in a timely manner. Conducts evaluation of customer complaints; including documentation review, sample testing, and technical evaluation of product defects. Manages the resolution of customer complaints, within given timeframes; identifying the problem, defining containment actions, investigating root cause, establishing corrective and preventive plans in order to eliminate or minimize the failures identified. Works closely with Operations and Quality to identify potential root causes and develop and implement appropriate corrective and preventive actions. Leads problem solving efforts to identify and resolve recurring and new quality issues to ensure production of safe and effective medical devices, which will result in product/process improvements, long-term solutions. Tracks effectiveness of corrective action plans and compliance improvement initiatives. Generates Situation Analysis Reports as needed, directed by the Associate Quality Manager (Supervisor), Quality Manager and other Directors in the Organization. Analyzes data and identifies trends in order to develop innovative solutions; using statistical techniques to identify significant changes and proactively initiates plans/projects to mitigate the risk. Generates weekly, monthly and quarterly reports and others as needed. Provides feedback pertaining to the groups involved in the complaint process. Maintains complaint files according to established polices/procedures. Supports company goals and objectives, polices, and procedures to maintain compliance with ISO 13485, FDA QSR and CE mark compliance. Maintain a professional working relationship with internal and external customer and support staff. Skills Limited / Basic application of technical principles, theories, concepts, techniques and quality sciences / tools such as: acceptance sampling theory and application, statistical process control methods and application, measurement systems / test method knowledge and analysis, quality planning, failure analysis and investigation, design of experiments, process mapping and value stream analysis, hypothesis testing, descriptive statistics, process capability analysis, and Basic Quality Tools: pareto, box plots, histograms, scatter diagrams, etc..., risk management, supplier quality management, auditing, design / development tools, process validation, software validation, etcQualifications:
Education BA/BS Degree (Major: Mechanical or Manufacturing Engineering) Experience Minimum of six months experience working in a manufacturing environmentc

Responsibilities:
Develops solutions to routine problems of limited scope. Follows company procedures for areas of assigned responsibility. Limited knowledge of applicable regulatory, Corporate and/or Unit requirements Effective communicator; ensuring all complaints are acknowledged, investigated and completed in a timely manner. Conducts evaluation of customer complaints; including documentation review, sample testing, and technical evaluation of product defects. Manages the resolution of customer complaints, within given timeframes; identifying the problem, defining containment actions, investigating root cause, establishing corrective and preventive plans in order to eliminate or minimize the failures identified. Works closely with Operations and Quality to identify potential root causes and develop and implement appropriate corrective and preventive actions. Leads problem solving efforts to identify and resolve recurring and new quality issues to ensure production of safe and effective medical devices, which will result in product/process improvements, long-term solutions. Tracks effectiveness of corrective action plans and compliance improvement initiatives. Generates Situation Analysis Reports as needed, directed by the Associate Quality Manager (Supervisor), Quality Manager and other Directors in the Organization. Analyzes data and identifies trends in order to develop innovative solutions; using statistical techniques to identify significant changes and proactively initiates plans/projects to mitigate the risk. Generates weekly, monthly and quarterly reports and others as needed. Provides feedback pertaining to the groups involved in the complaint process. Maintains complaint files according to established polices/procedures. Supports company goals and objectives, polices, and procedures to maintain compliance with ISO 13485, FDA QSR and CE mark compliance. Maintain a professional working relationship with internal and external customer and support staff. Skills Limited / Basic application of technical principles, theories, concepts, techniques and quality sciences / tools such as: acceptance sampling theory and application, statistical process control methods and application, measurement systems / test method knowledge and analysis, quality planning, failure analysis and investigation, design of experiments, process mapping and value stream analysis, hypothesis testing, descriptive statistics, process capability analysis, and Basic Quality Tools: pareto, box plots, histograms, scatter diagrams, etc..., risk management, supplier quality management, auditing, design / development tools, process validation, software validation, etc