QA Team Lead

Cambridge, UK

The QA Team Leader will report to the Interim QA Manager and is responsible for leading and line-managing the QA Team. They will be responsible for ensuring that we work within the company’s Quality Management System in accordance with Company, International Standards and Customer requirements. The QA Team Leader will help implement and drive a culture of quality throughout the company and support the evolvement of the QMS to meet the changing needs of the business.

Key Tasks & Accountabilities

Quality Assurance

  • QMS – ensure that the QMS meets the current needs of the business and that we plan for and manage QMS change; bringing along stakeholders as the QMS evolves with business needs, markets and applications. Understand and maintain compliance to any additional relevant standards, directives (e. g. Low Voltage) and regulations identified as a requirement for the business
  • Representation – Provide cover where applicable for QA Manager. Represent QA at Quality Steering Group (QSG) and Project Meetings, take part in Risk Management, Gate reviews and represent QA during internal/external communications. Work with all departments to ensure that all QMS activities are implemented effectively and are operating to meet the needs of the business.
  • Processes – Maintaining relevance of Quality processes, e.g. change control, CAPA, document control, supplier evaluation, and play a support role in Post Market Surveillance activities
  • Metrics/Reporting – produce reports as required on the effectiveness of the QMS and other quality data to inform the management of the business. Define and monitor key quality metrics to present to QSG, Interim QA Manager
  • Audits – day to day management of internal, external and supplier audits including recruiting and training of internal auditors.
  • Documentation – Responsible for Q-Pulse eQMS and key user of Cognidox (Document Management System), writing and providing suitable training for the different types of documentation
  • Training – identify and provide quality training (internal and external) throughout the business including inductions, QMS, Q-Pulse, quality processes, standards, regulations, etc.
  • Standards – maintain awareness of any changes in standards and regulations to ensure changes are communicated to the business to allow time for implementation

Team Leadership

  • Objectives – Setting and maintaining clear expectations and purpose for the team and the individuals, ensuring each team member plays their part in delivering the company objectives
  • Resource – Ensuring the team has the capability and capacity to support the company objectives
  • Relationships – Empowering the team to work effectively, embrace change and reach its full potential. Creating a coaching culture in the team where constructive, timely feedback, active listening and employee well-being are supported
  • Performance – Managing performance through regular measurement, communication and appropriate corrective action to ensure you have a high-performing and engaged team.
  • Culture and Values – Understanding and being a role model for the Owlstone culture and values

Requirements

Education & Training

The successful candidate is likely to have a Quality related CPD log showing formal training and development activities related to ISO standards and European Directives.

Competencies

Essential

  • Stakeholder engagement - to be successful in this role, you need a strong ability to effectively engage and influence stakeholders (i.e. operations, projects, engineering, management, etc). The ability to take pragmatic approach rather than an autocratic one as appropriate is essential
  • Team building – you will be responsible for leading a small but effective team to support the Owlstone business. The composition of this team and the roles that they cover will be driven by your/QA Manager’s vision of how quality will work within the business and how it will support the business functions.
  • Change Management – Understanding and agreeing the level of change required as the company grows and evolves, the ability to support and communicate the changes and assist in the evolvement of the QMS accordingly in line with the business.
  • Document control - Experience of using a formal, version-controlled digital document management system in a QA context is essential.

Experience / Knowledge

  • Highly organised, pro-active and self-motivated team leader with experience in leading a QA team to support a QMS currently conforming to ISO 9001:2015 certification.
  • Experience of CogniDox, Q-Pulse or other digital document management systems.
  • Experience of using electronic approvals process for sign-off of documents.
  • Knowledge of MDD 93/42/EEC, MDR 2017/745, FDA, ISO13485, 21 CFR 820 is highly desirable.
  • Trained in a suitable selection of Quality Tools: Internal/External/Customer Audits, Risk Analysis, RCA etc

Skills

  • MS Office applications - intermediate / advanced level (particularly Excel)

Benefits

About Owlstone Medical

Owlstone Medical (www.owlstonemedical.com) is on a mission to save 100,000 lives and $1.5 billion in healthcare costs through the development and application of Breath Biopsy®. This involves collecting volatile organic compounds (VOCs) and respiratory droplets from breath, which can provide information about the metabolic activity and markers related to health and disease.

Breath sampling has substantial advantages for the early detection of disease and to enable precision medicine approaches to patient care. To realize these advantages, Owlstone Medical offers Research Products and Services for biomarker discovery and is developing tests in applications including cancer, liver disease, asthma, and environmental exposure. Our work includes partnerships with major organizations including AstraZeneca, GlaxoSmithKline, the Cleveland Clinic, and the NHS and our platform is in use at well over 100 clinical and academic sites worldwide.

Our leadership in-breath is underpinned by our world-class and varied team, including systems engineers, clinical scientists, analytical chemists, artificial intelligence specialists and clinical trials coordinators.

The Owlstone group also commercializes a range of highly innovative products based on its proprietary FAIMS chemical sensing technology in other markets including Scientific, Industrial Process Control, Military and Homeland Defense.

We offer a relaxed, friendly, flexible and international working environment with a strong and vibrant team-spirit. You will be rewarded with a competitive salary package that includes an Employee share options scheme and private medical insurance and your work will have a clear impact on people’s lives. If you want to experience the buzz of a thriving start-up company set to succeed on a global scale, Owlstone Medical could be the place for you.

We do not accept applications from agencies outside of our preferred supplier list. If you are concerned that your application has not been received by Owlstone Medical, please contact us using careers@owlstone.co.uk.


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Owlstone team members are engineers, scientists and entrepreneurs focussed on changing non-invasive medical technology

We are scientists, doctors, engineers and entrepreneurs on a mission to save lives through early detection and precision medicine

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