Senior Quality Operations Lead

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Job Description:

Johnson & Johnson is currently recruiting for a Senior Quality Operations Lead! This position can be located in Cornelia or Athens Georgia.

Position Summary:

Plans coordinates and directs quality assurance programs designed to ensure continuous production of products consistent with established standards by performing the following duties personally or through subordinates. At this level the position has a greater degree of impact on the business results and typically responsibility for managing a group of professionals.

Implement and lead 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 in in place and maintained at the required compliance level
• Driving Quality System efficient execution and reduced risk of non-conforming product

Duties & Responsibilities:

• Under general direction and in accordance with all applicable federal state and local laws/regulations and Corporate Johnson & Johnson procedures and guidelines this position:
• 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 required.
• Manages 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
• The individual has the necessary independence authority and responsibility to initiate action to prevent nonconformities enact remediation plans identify and document quality issues initiate recommend provide and verify so9ltions.
• 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 cooperation with other manufacturing managers to maximize 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.
• Reviews reports findings and makes recommendations for corrective action.
• Submits and administers budget schedules and performance standards.
• Supports and manages cost improvement projects.
• Acts as back up to QA Director for signature authority and meeting representation.
• 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.
• Enforces 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 management level
• For those who supervise or manage a staff 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
• Performs other duties assigned as needed

Qualifications:

Education:

A minimum of a Bachelors or Equivalent University degree is required.

Knowledge Skills & Capabilities:

• Generally Requires 8-10 Years Work Experience
• Bachelors degree in a Technical or Science field
• Eight (8) years active management experience including direct supervision and matrix management
• Thirteen (13) years related experience and/or training or an equivalent combination of education and experience
• Experience in front-room role with FDA (or similar) inspection and Notified Body inspection
• Successful management a multinational department and/or significant QA project
• Statistical and analytical problem solving. Certified in PE tools (preferred)
• Preferred knowledge of lean manufacturing and manufacturing processes
• Excellent oral communication and technical writing skills
• Good decision-making skills. Erroneous decisions or recommendation or failure to complete assignments would normally result in serious delays to assigned projects with considerable expenditure of time human resources and funds.

Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race color religion sex sexual orientation gender identity age national origin disability protected veteran status or other characteristics protected by federal state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.
Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants needs. If you are an individual with a disability and would like to request an accommodation external applicants please contact us via . internal employees contact AskGS to be directed to your accommodation resource.

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