Sr, Quality Engineer COYOL

at  Boston Scientific Corporation

QUALIFICATIONS

• BS in Biomedical, or Mechanical Engineering, or equivalent technical discipline.
• Minimum of 5 years of Medical device engineering experience
• Working knowledge of the FDA, ISO, EUMDR and the medical device industry quality requirements associated with product development, design controls, product risk management, and usability engineering.
• Travel approximately <10%, if required.
• Strong communication (oral and written) and presentation skills.
• Preferred English Level: 80-89%.
• Please submit Resume in English

ABOUT THE ROLE:

The Design Assurance Engineer is a quality engineer that directly supports medical device product development from concept through commercialization. You would be part of an Agile product development team for the Endoscopy division working in a fast-paced environment to develop and support New Product Development. Your main development team is co-located in the Coyol manufacturing site to enable quick decision making and proximity to manufacturing lines.
You will provide Quality Assurance/Process Engineering support to NPD/Manufacturing teams. Develops, establishes, and maintains quality engineering methodologies, systems, and practices which meet BSC, customer, and regulatory requirements. Serves as a Quality representative to improve awareness, visibility, and communication on quality initiatives to support assigned departmental, functional, site, divisional and corporate quality goals and priorities. Provides quality engineering support within technical development projects, new product development projects, sustaining existing product families, or system/services support.

YOUR RESPONSIBILITIES INCLUDE:

• Working knowledge of Design Controls. Provide quality and compliance input to project teams for project decisions and deliverables (i.e. Design Change Analysis, Design Inputs, Design Outputs, Test Methods, Design Reviews, Design V&V, Usability Testing, Process Validation and Labeling).
• Creation and review of Risk Management documentation such as Hazard Analysis, Task Analysis, Design Failure Mode and Effects Analysis (DFMEA) and Fault Tree Analysis (FTA).
• Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues (i.e. 5 Whys analysis, Is-Is Not analysis, DMAIC problem solving methodologies).
• Provide quality guidance to assure country specific compliance, and champion compliance to company policies, work instructions and SOPs.
• Fully conversant with validation techniques and associated regulatory requirements including analysis of customer feedback and complaints.
• Support effective quality assurance, process controls and metrics using data and statistical analysis to drive improvements and actions for manufacturing and assembly of products.
• Provide quality and compliance input for post market product sustaining activities, such as design changes, supplier auditing and surveillance, design concessions, product CE marking and safety certification, customer complaint investigations, NCEP’s, CAPA’s PIRs, Field Signals Evaluations and Field Actions.
• Support internal and external regulatory audits, as required.
• Support collection and analysis of key quality trending information and data for Management Review and Complaint Reviews. Understand and support linkage of field data and Risk Management.