Quality Systems Manager

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 Assurance

Job Category:

Professional

All Job Posting Locations:

San Angelo, Texas, United States of America

Job Description:

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

We are searching for the best talent for Quality Systems Manager.

An internal pre-identified candidate for consideration has been identified. However, all applications will be considered.

Purpose:

Plans, coordinates, and directs the quality assurance programs designed to ensure the continuous production consistent with the established standards through the following responsibilities, either personally or through his/her subordinates.

You will be responsible for:

Business Improvement

• Leads or support quality improvement initiatives, such as the characterization of processes and products that leads to continuous improvements / cost.

• Revision / analysis of the effectiveness of PDCA, Six Sigma, Kaizen, Lean Techniques and other tools and improvement programs.

• Performs benchmarking in order to develop more effective methods to improve quality.

• Establishes and formulates the quality metrics to maintain the quality assurance objectives and alignment with the objectives of the plant.

• Supports the development of quality engineering and the compliance with the quality with the adequate abilities for the introduction of new products and product life cycle management.

• Promotes and supports the implementation of quality, product and process improvement projects.

• Revises and approves Engineering Change Orders (ECOs).

• Evaluation, monitoring and analysis of the quality costs in order to maintain a quality system according to the medical industry standards.

Compliance / Regulatory

• Revises / analyzes if the current products and processes (including performed actions or decisions) comply with the regulations, such as the QSRs, ISO 13485, etc.

• Leads the preparations activities for regulatory agencies audits, including the active participation as “SME” or “Escort” (for example: FDA, JJRC, BSI, etc.).

• Revises and approves the answers to internal and external audit observations to ensure the compliance with the internal procedures and applicable regulations.

• Establishes and properly maintains the required documentation of quality assurance activities and/or quality systems.

• Ensures the performance of periodical audits of the line to evaluate GMPs, production controls, lot segregation and process audit according to JJPS. Checks the results of the audits of the area to ensure that the corrective and preventive actions are adequate.

Finances

• Defines, monitors and administers the central budget of the department/cost

New Products / Process Introduction

• Collaborates with NPI and with the operations and engineering departments to develop, conduct and approve validation strategies of products and processes.

Product Quality, Control and Disposition and Performance Standards

• Directs and attends to Revision meetings of NCs as a member of MRB.

• Revises and approves the investigations, bounding, documentation, revision and approval of the non-conformities (NCs), preventive and corrective actions (CAPAs), customer complaints and escalation of quality problems when applies.

• Responsible and owner of the identification of material, material segregation, classification of the types of defects, including the successful application of these techniques in the day-to-day in manufacturing.

• Provides direction and assigns reso