Quality Systems Analyst

Johnson & Johnson Innovative MedicineJacksonville, FL
3dOnsite

About The Position

Johnson and Johnson Vision Care is recruiting for a Quality Systems Analyst, located in Jacksonville, Florida. About MedTech Fueled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalized treatments. Your unique talents will help patients on their journey to wellness. Learn more at https://www.jnj.com/medtech This position will support the site administration and execution of the Quality Management System (QMS) Processes and support delivery of Quality System projects. In conjunction with Quality Systems management, this person will drive the flawless and compliant execution of the assigned processes to meet customer and business needs while ensuring the processes are in compliance with regulatory requirements. This position will support the administration of the sites’ Quality Systems including for example: Change Control, CAPA, Metrics Management, Site Management Review and Nonconformance Data Review Programs. The role will require the individual to proactively examine systems, processes, and standards to identify opportunities for improvement.

Requirements

  • Bachelors/University or equivalent degree in Quality/Engineering/Science or related field.
  • A minimum of two (2) years of professional experience working in the Manufacturing, Engineering, Quality Assurance or Regulatory Affairs industries.
  • Proficiency in English language (verbal and written) is required

Nice To Haves

  • Knowledge and understanding of Quality Systems regulated by domestic and foreign governments.
  • Ability to work on own initiative with high attention to detail and ability to re-prioritize workload as required.
  • Clear concise communication skills with ability to develop and give presentations on technical and quality/regulatory topics.
  • Strong interpersonal, conflict management, and organization skills.
  • Strong leadership and coaching skills.

Responsibilities

  • Administer and provide technical expertise for quality systems, which could include Global Change Control, Global Application Change Control, and/or CAPA.
  • Tracking and trending of quality systems data and quality performance metrics, identify improvement opportunities, and follow up on action items.
  • Contribute to the streamlining and standardization of JJVC quality systems, including but not limited to change control, Nonconformance, CAPA, management reviews.
  • Supports specified quality system processes & works directly with various internal customers to ensure compliance to site/sector/enterprise /franchise/regulatory requirements.
  • Identifies personnel that require training on the relevant processes and rolls out training as required.
  • Support the assigned processes during internal and external audits and acts as Quality Systems SME.
  • Participates in investigations and corrective action implementation for identified quality issues as required.
  • Assists in creating a culture of quality awareness and communicating the quality management system, good manufacturing practices (GMPs) and associated documents and procedures to all staff.
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