Quality Operations Manager

hace 5 días


Tijuana, Baja California, México Intuitive A tiempo completo
About the Role

We are seeking an experienced Quality Operations Manager to oversee and plan daily activities for our Product Release team. As a key member of our quality operations team, you will coordinate workload to ensure appropriate manpower is assigned to required activities.

Responsibilities
  1. Verify that Product Release tasks are well defined, and ensure the Product Release team is productive and processes are compliant with ISI operating procedures and instructions.
  2. Ensure training is appropriate and timely for the Product Release team.
  3. Review and approve timecard submissions and related requests.
  4. Verify manpower planning is aligned to internal customer demand, current and projected.
  5. Review individual contributors' performance and mentor as appropriate to continuously improve Product Release performance.
Requirements
  • Supervises Product Release personnel at assigned plant(s).
  • Performs individual contributor performance reviews, timecard management, and mentoring for assigned plant.
  • Establishes and manages Monthly/Weekly assignment of DHR, optimizing actions based on demand and manpower.
  • Manages daily Product Release operations to ensure compliance with regulatory requirements including GDP & GMP.
  • Reviews NCR and DN trends, taking action where necessary to drive down average duration and recurring incidents.
  • Supports Quality audits to manage accurate data required before, during, and after audit events.
  • Manages sterilization lots release according to data provided by sterilization suppliers and escalates adverse specification data or extended delivery dates.
  • Keeps KPI of Product Release updated according to the frequency required by Quality Management.
  • Supports multiple sites on SOP, DOP, WI documents update, and upgrade related to Product Release.
  • Fluent in English speaking and writing (80% or above).

Estimated Salary: $110,000 - $130,000 per year. The salary may vary based on location and experience. We are looking for a highly skilled professional who can bring value to our company. If you are a motivated and detail-oriented individual with excellent communication skills, we encourage you to apply for this exciting opportunity.



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