“Quality Assurance Support: Responsibilities and Qualifications”

Description

Provides overall quality assurance support to JJI/ELC Quality Management System. Establishes and maintains quality assurance programs, procedures and controls, to drive improvement initiatives. Key areas of focus compliance to J&J standards and stream line processes. Key areas of support provided to team members include; risk management/communication, process capability/process improvement, and quality assurance general support.

Trains the site in the areas of quality. Reviews work to ensure compliance with the standards. Schedules or performs training for all employees. Recommends changes to standard operational and working practices. Educates employees and observes to ensure understanding and compliance.

Duties and Responsibilities

• Build, improve and maintain the document control and training processes through daily interaction with cross-functional teams while meeting the requirements of ISO 13485 and other Quality Systems Regulation.
• Efficiently implement, complete, and improve the lifecycle of document management (creation, review, approval, and maintenance of all documents); issue and reconcile quality records in support of GDP (Good Documentation Practice)
• Plan and implement structured processes and tools to initiate and support change management activities as designated by the organization.
• Maintain all records related to their responsibilities according to the requirements of the current regulation and enterprise retention schedule
• Administrate of the PLM System Adaptiv and CDR and coordinate the efficient execution of system administrator tasks, change control and incident follow-up.
• Evaluate and bring up significant issues to leader’s; prepare metrics, reports, updates; provide detailed and summary communications to leadership regarding to the company goals and objectives; and review and provide feedback for site Standard Operating Procedures related to the functional area.
• Responsible for the general management of the site Quality Systems training program.
• Support internal and external audits and inspections; ability to communicate regulatory and process positions as an SME during regulatory inspections.
• Participate in internal and external site audits and audit preparation in support of documentation discussions.
• Assess, implement and supervise process capability for continuous improvement.
• Responsible for communicating business related issues or opportunities to next management level
• Responsible for ensuring personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures.
• Performs other duties assigned as needed

Qualifications

Experience and education

• A minimum of bachelor’s degree is required
• Interest in Quality Assurance and training

Skills

• Proficiency in English
• Strong written and verbal communication skills – specifically with the ability to efficiently connect with individuals in a clear, concise & effective manner
• Independent worker with attention to detail
• Rigor in following through action/task
• Demonstrate a strong Quality and Compliance mindset