Quality Assurance Supervisor
CooperVision
Costa Rica
hace 12 días

JOB SUMMARY

Supervise the activities related with Process Quality and Sterilization area : QA Final, Process Controls oversight and Sterilization / Backend (decanting) activities.

Lead the Process Flow Leader, Quality Control technicians and Direct Labor Operators in charge of the previous mentioned functions.

Accountable for :

Supervise QA Final Operators and Technicians

Supervise Sterilization / Decanting / Backend area and technicians

Monitor Process Performance and escalate issues as required

Provide direction to achieve Company Goals

Develop Personnel (Process Flow Leaders, Technicians and Operators)

Manage the segregation and disposition of non-conforming product

Assure Compliance with Laws and Regulations

Payroll Administration / Kronos

Monitor Procedure vs Practice adherence on the QA Final area

Promote adequate communication with other departments

Provide support on Quality issues identified in the Operations Area

Manage inventory control (Finish Goods, Work In process, Rework material)

Process and / or Equipment qualification / validation

POSITION QUALIFICATIONS

KNOWLEDGE, SKILLS AND ABILITIES

Process Quality in a Medical Device Environment

Basic Statistical knowledge (Control Charts, Standard Deviation, Variation, Process Capability)

Excellent oral / written communications skills

Supervision skills (monitor daily performance, employee evaluations, perform training, assure Quality & Compliance in all activities within the area)

Perform non-conforming events investigations, including CAPA

Understanding, analysis and reporting of Quality Metrics

Ability to work with minimum supervision and take risk-based decisions.

Ability to negotiate with counterparts in order to make business balanced decisions

Provide guidance to assure compliance on Medical Device Regulations

WORK ENVIRONMENT

Work on a Production Area Environment

Require to move across the manufacturing room with frequent gowning and de-gowning process

Constant desktop work

Learn measurement techniques on different instruments like (OmniSpec, Optimec JCM, Dokumator)

Required to read high volume of documentation in Computer Monitor or Print information

Available to work on different shifts

EDUCATION

Bachelor in Industrial Engineer or related field.

EXPERIENCE

Minimum of 5 years in supervision functions

Minimum of 5 years of experience in the Medical Device or Pharmaceutical industry

Experience in problem solving activities.

Minimum of 3 years of experience in Process Quality Functions

Incoming Inspection experience (preferred)

Preferred CQE or equivalent certification, six sigma, lean process

The above statements are intended to describe the general nature and level of the work being performed by people assigned to this work.

This is not an exhaustive list of all duties and responsibilities. CooperVision, Inc. reserves the right to amend and change responsibilities to meet business and organizational needs as necessary.

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