Johnson & Johnson Careers
Staff Quality Systems Specialist
Requisition ID: 1905715013W
Title: Staff Quality Systems Specialist
This position will lead the execution of the Site’s Quality Management System Processes providing quality leadership and support. This person is responsible for leading and implementing Quality System Projects and Continuous Improvement initiatives at the site and across sites as required.
This person will drive and lead 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 lead role will involve liaising with the Franchise/Sector/Enterprise teams on driving improvement and streamlining of the assigned processes.
This person is responsible for ensuring quality systems processes are maintained and improved in line with Sector, Enterprise and applicable standards and regulations
Main areas of responsibility:
− Oversees and directs the routine day-to-day departmental activities
− Manages specified quality systems
− Performance and Development Planning and Evaluations for Quality Systems Team Members
− Provides continuous support and mentoring to Quality Systems Specialists and Department members
− Collaborate and partner with stakeholders across multiple functions to identify and deliver Improvement initiatives
− Conduct strategic planning with Quality System Manager
− Leads compliant execution of the following for their assigned processes and projects:-
• Works directly with various customers of the quality system processes to ensure compliance to site, sector/enterprise/franchise/regulatory requirements
• Lead and Deliver Site Quality System initiatives and projects including managing resource requirements, timeline for delivery and utilization of appropriate quality tools for effective results
• Identifies assesses and mitigates risk
• Support both Internal and external audits, act as Quality Systems Subject Matter Expert
• Accountability and ownership of Quality metrics including tracking, trending and communicating leading and lagging indicators of quality
• Review/analyze the effectiveness of PDCA, Six Sigma, Kaizen, Lean Techniques and/or other improvement tools and programs as part of the Continuous Improvement Program
• Responds to and leads/drives investigations and corrective action implementation for identified quality issues including internal/external audits actions
• Represents the processes as required at cross-site and global meetings/forums
• Identifies personnel that require training on the relevant processes and rolls out training as required
• Assists in creating a culture of quality awareness and communicating the quality management system, GMP and associated documents and procedures to all staff
• Establishes linkages to other key quality systems/programs like Design Controls, Technology Transfer, Production & Process Controls, External Manufacturing, Calibration, Preventive Maintenance, etc.
− Performs other related duties as assigned by management
− Responsible for compliance in accordance with regulations such as and from, but not limited to, FDA Quality System Regulation, ISO 13485, EU MD Directive/Regulations, FDA Combo Product Regulation 21 CFR Parts 4 with 21 CFR 210/211 as applicable, Japanese MHLW, Health Canada, Brazilian ANVISA, Australian TGA for the company's products including medical devices and combination products.
Education and Experience Required for Role
− Minimum of a Bachelor’s degree in a science/engineering or related discipline
− Generally requires 5-8 years’ industry experience working in a Quality Assurance regulated medical device or pharmaceutical manufacturing environment
− Experienced SME for FDA and other regulatory authority audits.
− Excellent leadership skills
− Successful Completion and Leadership of Internal and Global Projects
− Strong mentoring, coaching and leadership skills are required.
− Demonstrated excellence in presentation and meeting facilitation skills
− Proven success in the execution and application of quality systems, including the application of statistical principles, theories, and concepts
− Working knowledge of analytical software (e.g. SPC/Minitab, etc.).
− Proven problem solving skills
− Ability to work on own initiative
− Flexible work ethic
− Innovative development techniques and strategic thinking abilities
− Ability to prioritize and handle multiple tasks, and to facilitate and resolve cross functional activities and issues
− Demonstrated project management and project leadership abilities are required
Johnson & Johnson Vision Care (Ireland) Limited (8182)