Johnson & Johnson MedTech · 1 day ago
Quality System Lead
Irving, TX
Full-time
Onsite
Senior Level, Lead/Staff
8+ years expJohnson & Johnson MedTech is a leader in healthcare innovation, striving to prevent, treat, and cure complex diseases. The Quality Systems Lead oversees the Quality Systems staff, managing processes related to Document Control, Records Management, Nonconformance, and CAPA programs to ensure compliance and continuous improvement within the organization.
Hospital & Health Care
Responsibilities
Manage the NC and CAPA processes and systems for the site
Manage the Document Control and Records Management processes for the site
Manages the implementation and administration of quality management systems in accordance with applicable standards
Requests data and metrics reports obtained from quality databases and files for inclusion in management reports
Examines results from management reviews, third party inspections and internal audits and approves proposed corrective actions
Represent the site on the world-wide Document Control, Records Management, NC and CAPA teams
Work effectively with other Document Control, Records Management, NC, and CAPA site leaders to ensure consistent systems and processes
Provide education and mentoring as needed regarding Document Control, Records Management, NC, and CAPA
Develop and implement measures to monitor the effectiveness of the Document Control, Records Management, NC, and CAPA systems
Lead quality systems and compliance improvement, which result from Internal / External Audits, Management Review and / or any other CAPA / NC system indicator
Participates as a key member in both external and internal audits and is responsible for the local Document Control, Records Management, NC, and CAPA processes and directed inspections
Represents the site and collaborates with business partners as the CAPA Site Leader
Facilitates (or delegates Facilitation) and leads the site CAPA Review Board / Data Review Board / Quality Metrics Review / Management Review
Partner with management to develop and implement meaningful trending of Change Management, NC and CAPA performance
Leverage Process Excellence tools to effectively implement CAPA using a DMAIC approach
Responsible to mentor both technical and non-technical resources in investigation, troubleshooting, escalation, and resolution of product and process quality issues, NC and CAPA
Supports the continuous improvement of the Document Control, Records Management, CAPA and NC processes and electronic system for managing CAPA and NCs
Demonstrate independent understanding and application of core GMP fundamentals, including but not limited to: Data Integrity (DI), Good Manufacturing Practices (GMP), and Good Documentation Practices (GDPs)
Responsible for communicating business related issues or opportunities to next management level
Responsible for following all Company guidelines related to Health, Safety and Environmental practices as applicable
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
University/Bachelors Degree or Equivalent
8 – 10 years of work experience required
Experience leading NCs and CAPAs
Experience in Change Management and Document Control
Experience in Records Management
Knowledge of regulatory requirements (ISO, QSR, etc.)
Experience with external auditing bodies
Demonstrated project management skills with strong results orientation, required
Strong communication, influencing and presentation skills, required
Preferred
Process Excellence Green Belt Certification with demonstrated problem-solving and statistics skills, preferred
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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