Senior Manager, QA Engineer

at  Boston Scientific Corporation

Job Description

ABOUT THE ROLE:

The Quality Manager is responsible for designing, planning, coordinating and executing projects oriented towards quality improvement in the site´s manufacturing processes. Provides support to Process Quality and Quality Engineering areas management. Establishes and maintains Quality Management systems that meet regulatory requirements, corporate policies, internal policies and business needs. Additionally, he/she is responsible for planning and supervising In Process Quality Engineers functions and activities.

YOU’RE RESPONSIBILITIES INCLUDE:

• Coordinate Quality Engineering and In Process Quality Engineering areas engineers’ functions and activities.
• Provide support to new products/process transfer projects; review risk analysis (PFMEA) for the different processes.
• Plan, coordinate and execute projects oriented towards in process defects prevention.
• Design and implement process control strategies.
• Facilitate and support the Quality Control supervision function through Quality Engineers and Quality Supervisors.
• 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 In Process Quality area and to other departments.
• Deliver training related to quality technologies.
• Coordinate with Corporation the implementation of projects related to the In Process Quality area.
• Create new procedures on In Process Quality 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, 820.70 Production and Process Controls, 820.75 Process Validation, 820.60 Identification, 820.65 Traceability, 820.72 Inspection, measuring and test equipment, 820.90 Non-conforming product, 820.80 Receiving, in-process and finished device acceptance, 820.100 CAPA, 820.198 Complaint Files.
• 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 provide support to the Quality Director in his/her responsibilities. Authorized to sign as the Quality Director designee or representative in his/her absence or as required.
• 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.