Staff Process Quality Lead

At Johnson & Johnsonwe believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented treated and curedwhere treatments are smarter and less invasive andsolutions are 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 more at

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About MedTech

Fueled by innovation at the intersection of biology and technology were 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 Surgery

Fueled by innovation at the intersection of biology and technology were developing the next generation of smarter less invasive more personalized treatments.

Are you passionate about improving and expanding the possibilities of surgery Ready to join a team thats reimagining how we heal Our Surgery team will give you the chance to deliver surgical technologies and solutions to surgeons and healthcare professionals around the world. Your contributions will help effectively treat some of the worlds most prevalent conditions such as obesity cardiovascular disease and cancer. Patients are waiting.

Your unique talents will help patients on their journey to wellness. Learn more at are searching for the best talent for Staff Process Quality Leader to be in Cd. Juarez in Plant Independencia.

Purpose:

The Process Quality Lead position is established to enhance the Quality activities on the business unit such as nonconformances complaints attend internal and external audits audit observations resolution quality indicators escalation processes CAPAs DRB PQSS and any quality issue affecting the business unit. Promote Quality Culture in Operations and Lead & engage strategies for risk management.

You will be responsible for:

• Develop and supervise effective defect tracking mechanisms and coordinate improvement actions.
• Lead efforts and projects to improve quality performance for the Business Unit including InProcess Reporting Software Upgrades to systems etc.
• Lead quality system improvements which result from internal audits QLT and Quality Board Issues as required.
• Responsible for the appropriate execution of Quality Assurance test methods and inspections procedures of raw material work in progress and finished product for the Business Unit.
• Establish and maintain programs procedures and controls ensuring that product and raw materials are manufactured and controlled as per established procedures specifications medical device regulations sterilization guidelines and ISO standards.
• Support cost savings opportunities that work toward achieving the objectives of the Business Unit.
• Responsible for ensuring compliance with procedures for all nonconforming product and raw materials applicable to the Business Unit.
• Support projects and new product introductions by establishing key checkpoints for new products and processes.
• Ensure compliance with company policies and procedures.
• Promote the use of quality metrics and performance data to drive improvements. Page 2 of 7
• Support efforts in the use of Process Excellence tools to enhance analytical thinking and problem-solving techniques.
• In depth knowledge and analysis of voice of the customer (product complaints) and lead process improvements in collaboration with Engineering and Manufacturing to reduce or eliminate Product Complaints.
• Active participant in CAPA council boards (plant and franchise) and Management Review to identify and lead process improvements to reduce or eliminate complaints.
• Establish a process to assess the use of internal quality data as a predictor to reduce/eliminate product complaints.
• Work with Materials Planning and Manufacturing to facilitate testing and release of product. Review and participate in personnel development programs necessary to provide employee movement through prescribed promotional patterns.
• Evaluate and recommend staffing requirements to optimize the utilization of personnel to fulfill Business Unit objectives.
• Responsible for the coordination of Business Unit activities with QA partners for corrective and preventive actions.
• Acts as CAPA owner and coordinator as determined by the Business Unit Manager or Director.
• Acts as Risk Escalation Owner to drive investigation and communication to Risk Management Board.
• In conjunction with QA partners prepares presentations for QLT and QB meetings and represents the Business Unit in CAPA reviews.
• Track and monitor CAPA metrics for the Business Unit and drives actions for improvement.
• Lead improvements in quality performance metrics for the Business Unit such as responses to internal and external audits NCR QNC compliance training etc.
• Ensure compliance to the quality policy in all activities.
• Promotes Quality Culture in Operations by facilitating trainings quality talks and other engagement strategies.
• Support and promote the safety and industrial hygiene objectives of the site.

Qualifications / Requirements:

• See Table Job Experience Requirements for each level.
• Experience in Medical Device Industry preferred.
• A Minimum of BS in Engineering.
• CQE (ASQ) Certified preferred.
• Certification in Lean Manufacturing or Six Sigma is preferred.
• Include Staff Process Quality Leader duties in addition:
• The Principal Process Quality Leader plans directs and conducts projects of major scope and significance to the organization with full technical responsibility for interpreting organizing executing and coordinating assignments. They may contribute inventions designs or techniques which are materially significant in the solution of important problems. Experience in CAPA process as a CAPA Leader Provide oversight feedback and coaching to Staff PQL Provide feedback in external forums as SME Lead complex projects were involved different functional areas Liaison with External parties where involve quality nonconformances and improvements.
• Generally requires 8-10 years related experience.
• Proven initiative creativity assertiveness and leadership skills.
• Must be able to work under pressure achieving consistently high results through individual and team efforts.
• Masters Degree (preferred).
• Excellent interpersonal influencing communication presentation listening and negotiation skills.
• Ability to set priorities and achieve objectives.
• Excellent analytical and statistical skills.
• Proven skills in root cause analysis problem resolution and documentation practices.

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