Operations Quality Assurance Lead

Additional Locations: N/A

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.

Job Purpose

• Lead NCEP, CAPA, PIRE/PIR processes and mentoring
• Lead QA Management Review, quality metrics and governance
• Drive major quality, compliance and improvement initiatives
• Support QA priorities, escalations and cross-functional quality activities
• Act as QA Manager delegate when required
  
  

• Manage of QA engineers
• Lead and coordinate NCEP, eCAPA, PIRE and PIR activities, including recurring reviews and timely completion of QA actions
• Lead OPS QA Management Review, including data collection, analysis and KPI definition/adjustment
• Lead QA task forces and quality improvement initiatives
• Lead 2nd and 3rd Tier Quality meetings, including agenda preparation and follow-up
• Support special projects and lead QA activities for NPI
• Serve as Service & Field Complaints POC, assign investigation owners and ensure feedback to relevant stakeholders
• Create and maintain Quality Plans (QPTP) and QSPD, as applicable
• Lead ZRD Special WKO activities for new and modified production processes
• Lead periodic QA SOP review and maintenance
• Lead OPS QA internal/external audit readiness and facilitation
• Act as QA Manager delegate, when required
  
  

• BSc degree in Quality/Statistics/Biomedical/Mechanical/Electronic/Biotechnology Engineering, or a related field.
• Minimum of 7 years of relevant Quality experience in Medical Devices/Defense/Aviation industry
• Minimum of 5 years of experience in a Quality leadership or management role
• Experience with multidisciplinary products
• Strong knowledge of nonconformance management, process validation, risk management, V&V, and transfer to production
• Knowledge of statistical techniques and experience in data analysis and presentation
• Experience with ERP systems, such as SAP
• Strong multitasking, prioritization, and results-oriented skills
• Strong interpersonal and communication skills
• Fluent English, both written and spoken