Quality Director

Optos was founded on the mission to revolutionise retinal imaging and save sight, with the introduction of an innovative, patient-friendly device that captures a digital, ultra-widefield image of the retina.  Today, millions of patients around the world have benefited from optomap® retinal imaging.

As a division of Nikon Co. Ltd, Japan since 2015, Optos is proud to be recognised as a leading provider of ophthalmic products and services to eye care professionals that provide a more complete approach to patient care.

Optos core products produce high resolution optomap images of 82% or 200◦ of the retina, something no other imaging device is capable of in a single comfortable capture. Their devices facilitate the early detection, management and effective treatment of disorders and diseases evidenced in the retina such as retinal detachments and tears, glaucoma, diabetic retinopathy, and age-related macular degeneration.

Optos is seeking an experienced Quality Director to plan and direct quality activities in support of the company’s quality assurance operations.  You will be responsible for developing and executing the company’s quality management system to meet internal and external customer requirements as well as managing 3^rd party audits.

This role helps to determine the global QA strategy, managing a group of professionals in the UK and the USA and reporting to the VP Global Quality.  We are looking for the Director of Quality to establish a world class benchmark in quality against which to measure and report Optos’ progress.

We would love to hear from candidates with:

• Degree in sciences, life sciences, engineering or quality management or equivalent education gained through work experiences.
• Excellent practical experience of quality systems.
• Working within the highly regulated medical device market.
• Good awareness of FDA & MHRA systems and procedures.
• Qualified lead auditor.
• Sound awareness of quality issues within a supply chain environment.
• Previous experience in IVD/Medical Device related industry is desirable.
• Knowledge of ISO 9001/13485
• Knowledge of cGMP/Quality System Regulations
• Extensive use of Electronic Quality Management Systems

We are looking to appoint a highly skilled, adaptable and credible leader into this position.  He or she will have great communications skills, be able to engage with stakeholders internally and externally, be diligent and robust and a strong all round leader.

Optos is an Equal Opportunity/Affirmative Action Employer