At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com

Job Function:

Quality

Job Sub Function:

Quality Systems

Job Category:

Professional

All Job Posting Locations:

Jacksonville, Florida, United States of America

Job Description:

Johnson and Johnson Vision Care is recruiting for a Senior 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 execution of the Sites' Quality Management System (QMS) Processes and deliver Quality System projects. 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 role will involve liaising with the Franchise/Sector teams on driving improvement and streamlining of the assigned processes.

This position will also 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.

Key Responsibilities:

• Manages specified quality system processes & works directly with various customers of the quality system processes to ensure compliance to site/sector/enterprise /franchise/regulatory requirements.
• Works directly with the various owners/teams to ensure investigations/actions are implemented and accurately documented in a timely manner.
• Compiles, evaluates and presents Quality Systems data and metrics utilizing statistical methods and quality tools to track, trend and communicate quality performance.
• Proactively examines/reviews systems and processes, to identify areas for improvement, change, or elimination with specific focus on simplifying and standardizing processes. Lead and drive improvements as required
• Identifies personnel that require training on the relevant processes and rolls out training as required.
• Establishes linkages to other key quality systems/programs like Design Controls, Technology Transfer, Production & Process Controls, External Manufacturing, Calibration, Preventive Maintenance, etc.
• 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.
• Supports the Quality Systems Manager in the planning and directing of overall Quality System activities, as required.
• Provides continuous support and mentoring to Quality Systems Specialists.

Qualifications

Education:

• Bachelors/University or equivalent degree in Engineering or Science is required.

Experience and Skills:

Required:

• A minimum of four (4) years of professional experience working in the Manufacturing, Engineering, Quality Assurance or Regulatory Affairs industries.

Preferred:

• Proficiency in applicable external regulations and standards e.g. 21 CFR 820, ISO 13485:2016 and an in-depth knowledge of Quality Systems.
• Understanding and application of principles, concepts and practices of Risk Management, Statistical Methods, Change Control, Root Cause Analysis/Failure Investigation.
• Experience in supporting Internal/External audits.
• Ability to work on own initiative with high attention to detail and ability to re-prioritize workload.
• Clear concise communication skills with ability to develop and give presentations on technical and quality/regulatory topics.
• Excellent communication, interpersonal, conflict management, and organization skills. Strong leadership and coaching skills.

Other:

• Proficiency in the English language (verbal and written) is required.
• Up to 10% travel may be required for this position.

Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.

Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants’ needs. If you are an individual with a disability and would like to request an accommodation, external applicants please contact us via https://www.jnj.com/contact-us/careers. Internal employees contact AskGS to be directed to your accommodation resource.

 

 

Required Skills:

 

 

Preferred Skills:

Analytical Reasoning, Business Alignment, Business Behavior, Coaching, Collaborating, Communication, Compliance Management, Data Compilation, Data Quality, Data Savvy, Document Management, Problem Solving, Quality Auditing, Quality Control (QC), Quality Management Systems (QMS), Quality Services, Quality Standards, Systems Analysis, Training People