Quality Officer

Role Type: Permanent, Full Time

Hours: 37.5 per week

Location: Central Bristol, United Kingdom

Application Closes: 05/09/2019 at 5:00pm

Salary: £30-32k per annum

Open Bionics Ltd is a Bristol based company who design, develop and manufactures bionic limbs for amputees. Our mission is to: “Create and Democratise Technology that Enhances the Human Body”. We want to make beautiful bionic limbs more accessible and to turn our users’ disabilities into superpowers! We’ve won several awards and was recently named as one of Fast-Company’s most innovative companies in the whole of Europe. Feel free to visit our website to find out more about us: www.openbionics.com.

As the Quality Officer, you will have excellent knowledge of risk management and ISO standards relevant to medical devices, namely ISO13485 and ISO14971. You will be the subject matter expert for risk management and you will be expected to provide direction when queries arise, justifying your responses in line with regulatory requirements. 

As well as making decisions and influencing others, you will be a key enabler of helping to drive a culture in which quality and compliance is everyone’s responsibility, and ensuring we continue to work in an ethical and transparent manner.


Role Specification

Reporting to the Quality Manager, your main responsibilities include:

  • Making recommendations on Corrective and Preventive Actions (CAPAs) and Non-Conformity Reports (NCRs) including but not limited to establishing root causes, taking investigative action, advising on any necessary preventive measures and liaising with the teams responsible for executing them effectively.
  • Management of CAPAs and NCRs to ensure they are clearly documented, compliant and dealt with in a timely manner.
  • Using appropriate risk management tools, such as FMEA or FTA.
  • Continual maintenance of Open Bionics’ product risk management files.
  • Scheduling, leading or contributing to risk management review meetings.
  • Working with colleagues across all departments to analyse product risks.
  • Using knowledge of ISO13485 and ISO14971 to plan and conduct internal compliance audits.
  • Preparing compliance documents for regulatory submissions.
  • Support the total quality processes for Open Bionics’ products.
  • Keep up-to-date with changes to relevant medical devices standards and regulations, and ensure that we are prepared to make any required changes to our internal processes and systems.

A successful first year at Open Bionics would include:

  • Supporting the roll out of a new CAPA process so it is in full operation and ensuring colleagues understand it.
  • Ensuring that the CAPA completion rate is in line with the process and within timeframes.
  • Maintaining our current risk management files and updating with post-market data.
  • Keeping an up-to-date database of records and compliance documentation.

For any role specific related queries, please contact emma @openbionics.com.

Person Scorecard

  • At least 3 years’ experience working in quality or compliance within a medical device company.
  • Working knowledge of ISO13485 and ISO14971.
  • Evidence of strong written communication skills.
  • Evidence of excellent analytical and decision making skills.

Desirable

  • Internal auditor trained to ISO13485.
  • Knowledge of ISO60601.

To Apply

1) Write a Covering Letter explaining why you are suitable for the role. You should address the person scorecard criteria and detail why you want to work for Open Bionics.

2) Upload your CV.

Please note that both of the above must be provided in order to be considered for the post.

Benefits

32 days annual leave including bank holidays (pro rata)

Pension Scheme

Cycle Scheme

50% subsidised Gym/Sports membership or exercise classes

50% subsidised language classes

Flexible working hours

Paid Professional Membership (if applicable)

Monthly socials

Free Fruit

Free Tea & Coffee

Other Information

Open Bionics is an Equal Opportunities employer. If you are disabled and require any reasonable adjustments, please contact james @openbionics.com.

We welcome enquiries from everyone and we value diversity in our workplace. We may operate positive action measures to encourage people from under-represented groups to apply and help them overcome disadvantages in competing with other applicants.

If you are successful, you will be expected to start within one month following the offer of an employment contract with Open Bionics Ltd and be expected to provide proof of your right to work in the UK.

Please note we are expecting to move our main office to central Bristol within the next few months.