Global Supplier Quality Engineer

Purpose

Work autonomously to lead supplier interactions on behalf of BVI worldwide to obtain, evaluate, approve, monitor and feedback information required for compliance and continuous improvement. Build positive relationships to enable effective collaboration and management of suppliers. Liaise with personnel across multiple sites and functions to investigate and remediate any issues as they arise.

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
• Coordinating activities relating to CAPAs/NCRs & SCARs for example root cause analysis investigations, responses, risk assessments
• Facilitating the site assessment of supplier notified changes and dealing with notification of internal changes to relevant suppliers
• Leading supplier audits and where necessary developing, agreeing and tracking progress to quality improvement plans
• Proactively reviewing Supplier risks, developing strategies for part and process Quality improvements as needed.
• Liaising with production, quality, supplier and technical personnel across multiple sites to identify and implement quality improvements.
• Preparing summary reports for and participating in management review and other formal review meetings.
• Supporting internal and external quality audits, including customer audits.
• Producing quality specifications, purchasing specifications and procedures for their consistent implementation.
• Adhering to the requirements defined within the Company’s health & safety, environmental and quality policies and systems.
• Staying up to date with industry trends and best practices, and proactively identify opportunities for continuous improvement
• Other duties as required
  
  

Qualification

• Minimum HNC/HND or equivalent in engineering or related Quality discipline and/or relevant experience gained within a regulated industry or similar manufacturing environment.
• Minimum of three years’ experience in a Quality Assurance role, preferably gained within the medical devices industry.
• Trained auditor to ISO 13485.
• Knowledge of medical device regulations (FDA, ISO 13485, MDD and EU MDR).
• Fluent in English (spoken and written)
• Computer literate with knowledge of Microsoft Office software (Excel, Word, PowerPoint).
• Good root cause analysis ability.
• Good interpersonal and communication skills, ability to form positive relationships.
• Ability to establish and maintain effective working relationships with co-workers, managers and suppliers
  
  

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