Process Quality Manager

hace 4 semanas

Juárez, Chihuahua, México Johnson & Johnson A tiempo completo

At Johnson & Johnson, we are committed to delivering high-quality products that meet the needs of our customers. As a Process Quality Leader, you will play a critical role in ensuring the quality of our products and processes.

The Process Quality Lead position is responsible for enhancing the Quality activities on the business unit, including nonconformances, complaints, internal and external audits, audit observations resolution, quality indicators, escalation processes, CAPAs, DRB, PQSS, and any quality issue affecting the business unit.

Key Responsibilities:

  • Develop and supervise effective defect tracking mechanisms and coordinate improvement actions.
  • Lead efforts and projects to improve quality performance for the Business Unit, including In-Process 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.
  • 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.

Qualifications:

  • 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.
  • 4-6 years related experience in a similar role.
  • Proven initiative, creativity, assertiveness, and leadership skills.
  • 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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