Global Supplier Quality Engineer

Purpose

As a Global Supplier Quality Engineer, you will work autonomously to provide strategic technical oversight of global suppliers from qualification & maintenance to discontinuation, ensuring design intent, process capability and product performance are consistently met across complex, high-risk components, assemblies and finished products. Build positive relationships to enable effective collaboration and management of suppliers working across multiple sites and functions to investigate and remediate any issues as they arise. Act as the technical authority for supplier process engineering, manufacturing controls, and advanced quality planning.

Key Responsibilities

• Qualification of new and ongoing evaluation / maintenance of existing critical suppliers with cross-functional support including coordinating the completion of supplier surveys, agreements and performance monitoring
• Provide expert guidance during supplier process development, scale-up, and transfer into production
• Lead deep-dive technical reviews of supplier manufacturing processes, including PFMEA, control plans, validation protocols, and process capability studies
• Lead complex, cross-site root cause investigations (for CAPAs / NCs / SCARs) using advanced engineering tools (DOE, fault-tree analysis, regression modelling), ensuring effective investigations, responses, risk assessments through assessing and challenging supplier engineering decisions, tolerance stack-ups, material specifications, and process controls
• Develop global supplier quality strategies aligned with business objectives, technology roadmaps, and risk-based sourcing plans including the proactive review of supplier risks, developing strategies for quality improvements as needed
• Represent Supplier Quality in global new product development (NPD) projects, ensuring Design for Manufacture, Design for Assembly, and supplier readiness
• Facilitate and contribute to the technical assessment of supplier notified changes and work with suppliers to assess and implement internal changes
• Lead supplier audits and where necessary develop, agree and track progress to quality improvement plans
• Facilitate and contribute to cross-functional technical reviews with production, quality, supplier and technical personnel across multiple sites to identify and implement quality improvements including global supplier improvement programs
• Prepare summary reports for and present in quality review meetings
• Support internal and external quality audits, act as BVI representative at customer and/or regulatory audits of suppliers
• Stay up to date with industry trends and best practices, and proactively identify opportunities for continuous improvement

Position Requirements

• Up to 50% travel
• Flexibility of hours to accommodate interactions with different timezones

Qualification

• Bachelor’s degree or equivalent is required in a science or engineering discipline
• Minimum of 7 years of experience in Quality Assurance/Quality Engineering within the medical device or pharmaceutical arena
• Lead auditor to ISO 13485
• Ability and willingness to travel frequently, primarily across the United States and Mexico, with flexibility to support suppliers across different locations and time zones

About the Company

BVI® is refocusing the future of vision. As one of the fastest-growing, diversified surgical ophthalmic businesses in the world, our purpose-built portfolio of trusted brands includes: Beaver® (Knives and Blades), Visitec® (Cannulas), Malosa® (Single-Use Instruments), Vitreq® (Vitreoretinal Surgical Products) and PhysIOL® (Premium IOLs), and spans more than 90 countries. We’ve set our sights on touching the lives of millions of patients affected by conditions such as cataracts, refractive error, glaucoma, retinal disease, and dry eye. Unburdened by legacy or bureaucracy, we have developed our strategy around a simple concept – taking pride in delivering innovative solutions for our physicians and patients, based on their needs. We trust and empower our associates to make decisions and solve problems because collaboration drives us. Valuing agility, simplicity, and transparency, we stay committed to listening to our customers, delivering for our patients, and keeping the future in focus. Learn more at www.bvimedical.com.