Sr Process Quality Manager

Additional Locations: CARTAGO

Diversity - Innovation - Caring - Global Collaboration - Winning Spirit - High Performance

At Boston Scientific, we’ll give you the opportunity to harness all that’s within you by working in teams of diverse and high-performing employees, tackling some of the most important health industry challenges. With access to the latest tools, information and training, we’ll help you in advancing your skills and career. Here, you’ll be supported in progressing – whatever your ambitions.

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.

Your 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.

What We’re Looking For:

· Licenciature degree in Industrial, Electronic, Biotechnology, Electromechanical Engineering or related field

· English Level required: 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.

Requisition ID: 633304

Boston Scientific transforms lives through innovative medical technologies that improve the health of patients around the world. As a global medical technology leader for more than 45 years, we advance science for life by providing a broad range of high-performance solutions that address unmet patient needs and reduce the cost of healthcare. Our portfolio of devices and therapies helps physicians diagnose and treat complex cardiovascular, respiratory, digestive, oncological, neurological and urological diseases and conditions. Learn more at www.bostonscientific.com and follow us on LinkedIn.