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

Responsibilties

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

Required Qualifications

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

Requisition ID:  637318

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 .