**Sr Final Quality Assurance Manager**

hace 4 días

Mexicali, Baja California, México Intuitive Surgical A tiempo completo
About the Role

The **Sr Final Quality Assurance Manager** will be responsible for ensuring that the Final Quality Inspection function provides support to manufacturing operations by aligning and guiding resources to complete the function of performing inspection and testing of DaVinci surgical products prior to final product release.

This role will oversee and directly supervise all of the activities of the technical personnel in all Mexicali sites, in accordance with the organization's policies and applicable internal rules. The Supervisor will be responsible for interviewing and training associates, planning, assigning, and directing work, appraising performance, rewarding and disciplining associates, addressing complaints, and resolving problems.

The Supervisor will also lead continuous improvement activities and other projects assigned by management.

Key Responsibilities
  • Work with engineers to determine appropriate support activities for non-conforming and new products.
  • Coordinate training activities to ensure compliance with regulatory requirements and ensure cross-training and flexibility across the Quality Inspection group.
  • Identify and record any problems relating to the product, process, and the quality system.
  • Creation and modification of documents in the ACCS (Production Environment).
  • Participate with Process Engineers, Quality Engineers, and Operations Group Leaders in activities that will improve safety, cost, efficiency, and performance.
  • Close communication with Quality functions at other sites (SV, Arizona, W).
  • Lead and/or participate in continuous improvement activities, CAPAs.
  • Represents the Mexicali FQI function during internal and external audits and has an active participation on backroom activities.
  • Participate on process validation and verification.
  • New product final test process assessment.
  • Champion improvements in inspection method efficiencies to drive down cost of inspection. Provide metrics to management.
  • Perform budget planning.
  • Participate in weekly Quality Meetings and follow up on action items and improvements agreed upon.
  • Enforce Current Good Manufacturing Procedures (cGMP's) and company policies.
  • Establish, track, and report FQI goals and quality metrics.
  • Coordinate and communicate within and across departments to address quality issues.
  • Track recurring issues as needed to achieve root cause corrective action.
  • Assure all operations are performed in accordance to procedures.
  • Perform periodic audits to verify correct and consistent operations.
  • Interface on a daily basis with internal customers and teams to resolve nonconforming material issues.
  • Drive on-time inspections to support company objectives and deadlines.
  • Ensure training records are up to date and all training is completed on time.
  • Perform personnel activities such as annual reviews and mentoring.
  • Track headcount, interview candidates.
  • Analyze forecast and determine capacity requirements.
  • Support internal and external audits as necessary.
Requirements
  • Bachelor's degree, Engineering required.
  • 3-5 years relevant experience. (quality supervisor, quality engineer)
  • Bilingual.
  • Quality systems experience, internal auditor certification (preferred).
  • Established interpersonal and leadership skills.
  • Excellent communication skills including ability to provide written and verbal instruction.
  • Ability to be a learn quickly and understand complex products and processes.
  • Analytical, problem-solving, and root-cause analysis skills.
  • Ability to communicate effectively both verbally and in writing, up, down, and across organizations.
  • Accepting and adhering to high ethical, moral, and personal dealing with others values in decisions, communications, actions, and when dealing with others.
  • Ability to work independently and handle tasks with competing priorities effectively.
  • Ability to work across team organizations and diverse cultures.
  • Must be able to use all standard inspection tools, gauges, and applicable equipment, tools, and fixtures used to execute quality assurance procedures and test methods.
  • Flexibility, willingness to learn new tasks, ability to take-on a variety of responsibilities big and small, and the need to fill-in for others when needed are highly preferred attributes for this position.

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