Quality Systems Managers
C. R. Bard - Humacao Municipio, PR

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The QA Manager is responsible for the execution of the following programs and processes: Corrective and Preventive Action (CAPA), Compliant Management, Investigations, and related quality activities in the support of daily manufacturing operations. The Quality Operations Support Manager will provide direct supervision to the personnel, both exempts and non-exempts, with direct responsibilities on the areas described above (i.e.: Quality Engineers, Quality Technicians, Internal auditors).
This individual must fully employ and apply all currently established CAPA principles, theories, concepts and techniques. The QA manager will provide direction, conduct reviews and ultimately approve all facility CAPA plans as well as manage all CAPA files. The QA Manager will provide solutions to Quality problems that are subject to the CAPA process and assure that all CAPA activities are effectively completed per schedule. As defined by the facility procedures, the QA manager will summarize the performance of the CAPA system for the purpose of management review and will escalate issues based on inactivity and non-conformance situations.
In addition to managing the CAPA process, the QA Manager will be responsible for all facility field assurance activities including complaint investigations, trending, and corrective actions, and facility management of the Quality System Compliance Audit process. The QA Manager will serve as a liaison with other Bard divisions and manufacturing facilities to coordinate CAPA, Complaint, and MRR activities between BPR and the affected Bard divisions/plants.
The QA Manager will actively participate in activities in support of regulatory inspections and audits from FDA and other Regulatory audits. The QA Manager will actively participate as a member of the FDA readiness team and provide technical support during FDA inspections and Notified Body audits.

Summary of Position with General Responsibilities:

The QA Manager is responsible for the execution of the following programs and processes: Corrective and Preventive Action (CAPA), Compliant Management, Investigations, and related quality activities in the support of daily manufacturing operations. The Quality Operations Support Manager will provide direct supervision to the personnel, both exempts and non-exempts, with direct responsibilities on the areas described above (i.e.: Quality Engineers, Quality Technicians, Internal auditors).
This individual must fully employ and apply all currently established CAPA principles, theories, concepts and techniques. The QA manager will provide direction, conduct reviews and ultimately approve all facility CAPA plans as well as manage all CAPA files. The QA Manager will provide solutions to Quality problems that are subject to the CAPA process and assure that all CAPA activities are effectively completed per schedule. As defined by the facility procedures, the QA manager will summarize the performance of the CAPA system for the purpose of management review and will escalate issues based on inactivity and non-conformance situations.
In addition to managing the CAPA process, the QA Manager will be responsible for all facility field assurance activities including complaint investigations, trending, and corrective actions, and facility management of the Quality System Compliance Audit process. The QA Manager will serve as a liaison with other Bard divisions and manufacturing facilities to coordinate CAPA, Complaint, and MRR activities between BPR and the affected Bard divisions/plants.
The QA Manager will actively participate in activities in support of regulatory inspections and audits from FDA and other Regulatory audits. The QA Manager will actively participate as a member of the FDA readiness team and provide technical support during FDA inspections and Notified Body audits.

Essential Job Functions:
  • Manages the local CAPA, MRR’s, Complaint Handling, and Compliance Programs. Drive the implementation of effective Corrective/Preventive Actions (CAPA) processes, including:
    • o Reviews, evaluates, prepares evidence, and/or approves CAPAs for closure and effectiveness verification
      • o Manages all CAPA files
    • o Identifies areas for Quality improvements using appropriate sources of Quality data (i.e. Complaints, MRR’s, Production Yields, and Supplier Metrics)
      • o Assures sustainability of implemented CAPA actions
      • o Communicates CAPA system performance to appropriate Site Management
    • o Supports development of periodic reviews to identify systematic improvements for the Investigations and CAPA processes
    • o Uses CAPA Database systems, MS Access and Trackwise, to develop queries and reports as required by Site Management
    • o Participates in local quality improvements groups meeting to provide advice for taking appropriate actions for continuous improvements
    • o Develops, assists and/or implements procedures and systems, as required, to assure compliance with Corporate Quality Policies and standards
    • o Manages all facility field assurance activities including complaint investigations, trending, and corrective actions
      • o Manages the Quality System Compliance Audit process
    • o Establishes performance standards for each of his/her areas of responsibilities and ensures goals and objectives are consistently fulfilled
  • Provides direct supervision to Quality Engineers, Quality Technicians and Internal Auditors
  • Provides on-going technical support to Bard Puerto Rico-Humacao manufacturing facility for specific, or assigned, current or planned production at that location
  • Serves as technical liaison between Puerto Rico and other Bard Divisions, Quality organizations
  • Assists the Plant QA Director in the development, implementation and maintenance of the Plant Wide Quality System
  • Identifies, defines and/or manages a wide variety of improvement projects in support of divisional and Bard Puerto Rico goals
  • Ensure facility compliance with all regulatory requirements
  • Assures is trained before performing any task
  • Uses the required clothes, personal and security protective equipment according to the requirements of its operation
  • Complies with the cGMP's, Quality Standards and established policies and/or procedures
  • Executes other duties assigned by the supervisor

Basic Qualifications:

• Working knowledge of US FDA and International regulations governing the medical device industry (i.e. QSR, GMP, MDR, and ISO 13485:2003
• Strong managerial skills and ability to manage departmental budgets and ability to manage departmental budgets
• Knowledge of fundamental quality systems principles such as CAPA, Failure Investigation and Management Reviews
• Ability to establish performance standards for his/her areas of responsibility and to ensure performance requirements are consistently achieved
• Leadership, supervisory and development skills
•Demonstrated ability to plan and manage multiple projects
• Must be bilingual (English/Spanish) and must have good communication skills both oral and written

• Team work oriented

•Excellent interpersonal skills including the ability to interface and communicate effectively at all levels, both inside and outside the organization.

Education and/or Experience:

•Bachelor degree in Science.

•Must have eight (8) or more years experience in a Quality Assurance role in the Medical Device Industry

About this company
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C. R. Bard is no upstart in the world of medical devices. The company has been in the business for more than a century and introduced the...