Quality Operations Lead
Ethicon, a member of Johnson & Johnson's Family of Companies is recruiting a Quality Operations Lead to be located at Cornelia, Georgia.
Ethicon, part of the Johnson & Johnson Medical Devices Companies, has made significant contributions to surgery for more than 60 years from creating the first sutures, to revolutionizing surgery with minimally invasive procedures.
Our continuing dedication to Shape the Future of Surgery is built on our commitment to help address the world's most pressing health care issues and improve and save more lives.
Through Ethicon's surgical technologies and solutions including sutures, staplers, energy devices, trocars and hemostats and our commitment to treat serious medical conditions like obesity and cancer worldwide, we deliver innovation to make a life-changing impact.
For more information, visit www.
ethicon.
com (http:
//www.
ethicon.
com/).
/> The Quality Operations Lead implement and own the quality operations organization for the Ethicon Cornelia, Georgia site by:
Planning, coordinating, and directing quality assurance programs designed to ensure continuous production of products consistent with established standards Serving as the Quality Operations Site Lead and overseeing day-to-day quality operations Verifying that the Quality System is in place and maintained at the required compliance level Driving Quality System efficient execution and reduced risk of non-conforming product Are you interested in joining a diverse team delivering outstanding results to our customers? Apply now for this exciting opportunity! Duties &
Responsibilities:
Administers the deployment and utilization of resources for tactical day-to-day work.
This includes working with Operations, Material Management, and QA as the need arises.
Administers the control of raw material, work in process material, and finished goods to ensure proper identification, segregation, and control.
Establishes and maintains quality assurance programs, procedures, and controls.
Ensures that performance and quality of products conform to established company and regulatory standards.
Analyzes data sources significant quality trends and recommends actions as needed.
Reviews and approves non-conformances, CAPA, Audit Observations, Change Controls, Validations and Completion Reports, and other quality system documents or records as the need arises.
Leads the qualification and validation for all products and processes and quality control support activities.
Supports investigation, evaluation, and implementation of actions to eliminate root causes of non-conformances.
Responsible to initiate action to prevent nonconformities, enact remediation plans, identify and document quality issues, initiate, recommend, provide and verify solutions.
Ensures effective risk management process is implemented to prevent unanticipated failure.
Acts as advisor to subordinate supervisors or staff to help meet established schedules or resolve technical or operational problems.
Formulates and maintains quality control objectives and coordinates objectives with preproduction and production procedures in collaboration with other manufacturing managers to improve product reliability and minimize costs.
Ensures all such products meet and/or exceed company and local government standards.
Participates in auditing of production areas and systems.
Review reports findings and makes recommendations for corrective action.
Submits and administers budget schedules and performance standards.
Supports and leads cost improvement projects.
Acts as back up to QA Director for signature authority and meeting representation as necessary.
Responsible for Succession Planning, Goals and Objectives, and Salary planning for direct reports and subordinates.
Actively supports other plant functions in the implementation of company programs and projects.
Implements, promotes, and observes all safety, environmental, industrial hygiene rules and regulations established by the Company.
Responsible for communicating business related issues or opportunities to next level leadership.
Responsible for ensuring that subordinates follow all Company guidelines related to Health, Safety and Environmental practices and that all resources needed to do so are available and in good condition, if applicable Responsible for ensuring personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures.
Additional
Responsibilities:
Follow all federally regulated programs.
Adhere to J&J environmental and safety policies and guidelines.
Align with all job specific safety procedures and use PPE when necessary.
Follow quality system requirements as defined within procedures and instructions.
Use applicable software systems as needed for the job (e.
g.
, Compliance Wire, ADAPTIV, etc.
) Support LEAN and Six Sigma Initiatives.
Support Maintenance Excellence (ME2) including 6S and Operator Asset Care.
Use statistical and analytical problem-solving experience as required.
Excellent oral communication and technical writing skills Good decision-making skills.
Accurately complete records as defined within the job procedures (e.
g.
, manual and/or electronic documentation).
Recommended Skills Auditing Communication Decision Making Leadership Logistics Operations Maintenance Estimated Salary: $20 to $28 per hour based on qualifications.
Ethicon, part of the Johnson & Johnson Medical Devices Companies, has made significant contributions to surgery for more than 60 years from creating the first sutures, to revolutionizing surgery with minimally invasive procedures.
Our continuing dedication to Shape the Future of Surgery is built on our commitment to help address the world's most pressing health care issues and improve and save more lives.
Through Ethicon's surgical technologies and solutions including sutures, staplers, energy devices, trocars and hemostats and our commitment to treat serious medical conditions like obesity and cancer worldwide, we deliver innovation to make a life-changing impact.
For more information, visit www.
ethicon.
com (http:
//www.
ethicon.
com/).
/> The Quality Operations Lead implement and own the quality operations organization for the Ethicon Cornelia, Georgia site by:
Planning, coordinating, and directing quality assurance programs designed to ensure continuous production of products consistent with established standards Serving as the Quality Operations Site Lead and overseeing day-to-day quality operations Verifying that the Quality System is in place and maintained at the required compliance level Driving Quality System efficient execution and reduced risk of non-conforming product Are you interested in joining a diverse team delivering outstanding results to our customers? Apply now for this exciting opportunity! Duties &
Responsibilities:
Administers the deployment and utilization of resources for tactical day-to-day work.
This includes working with Operations, Material Management, and QA as the need arises.
Administers the control of raw material, work in process material, and finished goods to ensure proper identification, segregation, and control.
Establishes and maintains quality assurance programs, procedures, and controls.
Ensures that performance and quality of products conform to established company and regulatory standards.
Analyzes data sources significant quality trends and recommends actions as needed.
Reviews and approves non-conformances, CAPA, Audit Observations, Change Controls, Validations and Completion Reports, and other quality system documents or records as the need arises.
Leads the qualification and validation for all products and processes and quality control support activities.
Supports investigation, evaluation, and implementation of actions to eliminate root causes of non-conformances.
Responsible to initiate action to prevent nonconformities, enact remediation plans, identify and document quality issues, initiate, recommend, provide and verify solutions.
Ensures effective risk management process is implemented to prevent unanticipated failure.
Acts as advisor to subordinate supervisors or staff to help meet established schedules or resolve technical or operational problems.
Formulates and maintains quality control objectives and coordinates objectives with preproduction and production procedures in collaboration with other manufacturing managers to improve product reliability and minimize costs.
Ensures all such products meet and/or exceed company and local government standards.
Participates in auditing of production areas and systems.
Review reports findings and makes recommendations for corrective action.
Submits and administers budget schedules and performance standards.
Supports and leads cost improvement projects.
Acts as back up to QA Director for signature authority and meeting representation as necessary.
Responsible for Succession Planning, Goals and Objectives, and Salary planning for direct reports and subordinates.
Actively supports other plant functions in the implementation of company programs and projects.
Implements, promotes, and observes all safety, environmental, industrial hygiene rules and regulations established by the Company.
Responsible for communicating business related issues or opportunities to next level leadership.
Responsible for ensuring that subordinates follow all Company guidelines related to Health, Safety and Environmental practices and that all resources needed to do so are available and in good condition, if applicable Responsible for ensuring personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures.
Additional
Responsibilities:
Follow all federally regulated programs.
Adhere to J&J environmental and safety policies and guidelines.
Align with all job specific safety procedures and use PPE when necessary.
Follow quality system requirements as defined within procedures and instructions.
Use applicable software systems as needed for the job (e.
g.
, Compliance Wire, ADAPTIV, etc.
) Support LEAN and Six Sigma Initiatives.
Support Maintenance Excellence (ME2) including 6S and Operator Asset Care.
Use statistical and analytical problem-solving experience as required.
Excellent oral communication and technical writing skills Good decision-making skills.
Accurately complete records as defined within the job procedures (e.
g.
, manual and/or electronic documentation).
Recommended Skills Auditing Communication Decision Making Leadership Logistics Operations Maintenance Estimated Salary: $20 to $28 per hour based on qualifications.
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