Quality Assurance

**About Occuity**

At Occuity, we are pioneering ground-breaking technological solutions to alleviate some of humanity’s greatest healthcare challenges by developing technology that takes instant health diagnostic information simply by looking in the eye. With our clear vision and values, a world-leading team of experts, 9 international patents and more pending, we are developing a hugely innovative range of products that will improve the lives of millions of people around the world. Healthcare challenges are there to be solved and at Occuity, we have the vision and the technical ability to succeed. Occuity’s aim is for our accessible, non-contact, mobile diagnostic health devices to make repetitive, invasive monitoring a thing of the past.

At Occuity, we value being at the forefront of cutting-edge technology and we have an incredible team of people helping us do just that. Our employees are excited to be part of a team that thrives in a culture of innovation and imagination. Our success means that we are now expanding at a rapid pace and we are seeking truly exceptional people to join our team. We are looking for trailblazers, visionaries and the naturally inquisitive; those who can challenge and those who can inspire. At Occuity, every single person has a voice - and a vital contribution to make to our success.

If this sounds like you, why not join us on our journey?

**The Role**

As part of our ambitious growth plans, Occuity is now seeking an experienced Quality Assurance individual to help drive the development of a new generation of portable, hand-held diagnostic medical devices.

**Key Duties & Responsibilities**
- Training, qualification and mentoring of personnel within QC department and Quality Technicians
- Managing and maintaining the current QMS system
- Incoming inspection, final inspection, lot history review and packaging areas
- Managing and reporting on product-related nonconformities, including but not limited to NCRs, CARs and CAPAs
- Managing incoming verification, acceptance criteria and storage requirements of raw material and reports on supplier performance
- Reporting the status and progress of quality output and nonconformance mitigation
- Managing internal and external audits, including suppliers
- Identifying areas of improvement within the QMS and planning the implementation of change
- Managing and reporting into the Management Review and ensuring key objectives are me

**Experience, Skills & Qualifications**

**Essential**
- Minimum of 3 years' experience within a manufacturing and production-based medical devices business, regulated to ISO13485
- Currently in a quality role, with good, all-round knowledge of medical device quality systems
- Demonstrable experience in quality engineering field/topics such as process control; error proofing; failure investigation and root cause analysis; CAPA; data collection and analysis; batch records and in-process testing/checks
- Successful with influencing and driving results
- Ability to prioritise and make decisions, whist showing good problem-solving ability
- Positive attitude toward change and contribution to new ideas/ways of working
- High levels of vigilance with rigorous attention to detail
- Ability to lead cross functional projects to timely and effective conclusion
- Experience of planning, executing, and reporting internal, external audits and hosting auditing authority audits

**Desirable**
- Formally trained as an Internal or Lead Auditor for ISO 13485 would be advantageous

**Personal Attributes**
- Enthusiastic and passionate, you are a keen analytical thinker and problem solver
- Self-motivated, persistent and collaborative, you have a “can-do” attitude and approach
- A keen eye for detail
- Tenacious and persistent with a determination to go the extra mile to see all projects through to completion
- Equally capable of working independently or as part of a team
- An excellent communicator, you are adept at information sharing and contributing towards an open, positive team atmosphere
- You are excited about the prospect of making a real difference to people’s health around the world

**Equality & Diversity**

Occuity is committed to encouraging equality, diversity and inclusion among our workforce, and eliminating unlawful discrimination. The aim is for our workforce to be truly representative of all sections of society and our customers, and for each employee to feel respected and able to give their best.

Further details on our Equality, Diversity and Inclusion policy can be found online