Quality Assurance Manager
hace 6 días
The Quality Assurance Manager is responsible for designing, planning, coordinating, and executing projects oriented towards quality improvement in the site. Establishes and maintains Quality Management systems that meet regulatory requirements, corporate policies, internal policies, and business needs.
Key Responsibilities- Plan, coordinate, and execute projects oriented towards process defects prevention and overall quality improvement.
- Review and/or approval of documents, investigations, extensions, or another regulatory figure within the company's quality system, as an alternate representative of Quality Management.
- Provide technical support to the Quality area and to other departments.
- Coordinate Quality Engineering functions and activities.
- Deliver training related to quality technologies.
- Coordinate with Corporation the implementation of projects related to the Quality department.
- Create new procedures and/or improve the existing in order to facilitate and assure regulatory compliance.
- Responsible for acting as Subject Expert Matter (SME) of the following chapters of the company's quality system: 803.5 Individual Adverse Event reports, Production and Process Controls, Process Validation, Identification, Traceability, Inspection, measuring and test equipment, Non-conforming product, Receiving, in-process and finished device acceptance, CAPA, Complaint Files.
- Provide support to new products/process transfer projects.
- May design and implement process control strategies.
- May facilitate and support the Quality Control supervision function through Quality Engineers and Quality Supervisors.
- May participate as a core team member in the new products transfer process, representing Quality Assurance areas.
- May act as NCEP System administrator for the area: tracking and keeping NCEP investigations related to the area closed; area MRB administrator; area NCEP owner; perform continuous improvements in NCEPs for the area; coordinate with other NCEP administrators on actions executes and the impact on other areas.
- May participate in the PIR (Product Inquiry Report) process, assuring: diligent execution of activities related to the PIR, PIR assessment in the eCAPA system, PIR execution, and appropriate process communication to Corporation. May act as the Quality Director (Head of Quality) designee in PIR process activities.
- May provide guidance and supervision to process validation areas, software validation, complaint handling, MTAC, Calibration, Microbiology, supplier, Q process development, and/or design assurance.
- Licenciature degree in Industrial Engineer or Field Related.
- English Level desired: C1:(90-94%).
- Desired knowledge: Formal training on statistical and quality techniques, desirable ASQ Certified, Knowledge of Six Sigma, Lean, APQP or similar tools.
- Experience on managing regulations and complaints MDR / MDV.
- Experience managing people is a must.
- At least 7 years of experience in similar position.
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