Senior Quality Operations Lead

Johnson & Johnson•Cornelia, GA

About The Position

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com Job Function: Quality Job Sub Function: Quality Assurance Job Category: Professional All Job Posting Locations: Athens, Georgia, United States of America, Cornelia, Georgia, United States of America 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

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.
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.

Nice To Haves

Certified in PE tools (preferred)
Preferred knowledge of lean manufacturing and manufacturing processes

Responsibilities

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