Johnson & Johnson MedTech · 12 hours ago
Senior Quality Operations Lead
Athens, GA
Full-time
Onsite
Senior Level, Lead/Staff
8+ years expJohnson & Johnson MedTech is a leader in healthcare innovation, dedicated to improving patient outcomes. The Senior Quality Operations Lead will plan and direct quality assurance programs to ensure the continuous production of compliant products, overseeing day-to-day quality operations and managing a team of professionals.
Hospital & Health Care
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 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 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
Qualification
Required
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
Preferred
Certified in PE tools
Preferred knowledge of lean manufacturing and manufacturing processes
Company
Johnson & Johnson MedTech
At Johnson & Johnson MedTech, we are working to solve the world’s most pressing healthcare challenges through innovations at the intersection of biology and technology.
10001+ employees
Funding
Current Stage
Late StageLeadership Team
Mike Walker
CFO & VP of Finance DePuy Synthes
Tino Schweighoefer, MBA
CFO Monarch Platform
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