Leads quality assurance programs at Johnson & Johnson ensuring continuous product quality and compliance with standards. Manages a team and drives the quality operations for the site in Georgia.
Responsibilities
Plans, coordinates, and directs quality assurance programs designed to ensure continuous production of products consistent with established standards.
Serves 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.
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.
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.
Requirements
A minimum of a Bachelors or Equivalent University degree is required.
Generally Requires 8-10 Years Work Experience
Bachelor’s 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
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