Global Quality Specialist

Purpose

• Working as part of a remote team, you will collaborate with multiple stakeholders to drive harmonization and will be instrumental in the development, implementation and maintenance of a Global QMS
• You will provide support to multiple sites, providing expertise in Quality Systems areas such as collating and presenting key metrics, document control, EQMS administration, internal and external audits and CAPA oversight including supporting root cause analyses and training
  
  

Key Responsibilities

• Provide expertise for the development and implementation of a global QMS
• Collaborate with multiple sites and stakeholders to ensure effective implementation and continuous improvement of the QMS
• Support the management of global CAPAs, change controls and the electronic QMS
• Input, maintain and report on key metrics including monthly dashboards / review boards
• Support the management of the internal audit program including scheduling, sharing forums, auditor development programs and alignment activities
• Develop and deliver training programs related to the QMS to further BVI’s Quality Mindset
  
  

Qualification

• Bachelor's degree in science / engineering,
• In-depth knowledge of ISO 13485, EU MDR and FDA 21 CFR 820
• Lead Auditor to ISO 13485
• Fluent in English
• Experience with electronic Quality Management Systems
  
  

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