Job description

Quality Engineer

Oxford, UK

Job Title: Quality Engineer

Employment Status: Full Time, Permanent 

Practice: NPI

Location: Oxford

Salary: Competitive

Reporting into:  Senior Quality Engineer

Company:

Do you want to make a difference while advancing your career? Come join Osler.

We are a UK diagnostics company whose purpose is to enable anyone, anywhere, to access, understand, and act on their health, to live healthier, happier, and longer lives.

We are realising this through the development of the Osler Origin – a 'portable lab' capable of performing a wide range of testing, with lab-quality performance, in a portable, rapid, low-cost, and easy-to-use manner. The Osler Origin will offer a wide portfolio of diagnostic tests and serve all major healthcare settings, globally.

The Osler Origin is powered by a portfolio of novel techniques and approaches for sample addition, microfluidic sample preparation, and electrochemical biosensing, and Osler was formed out of the University of Oxford in 2017, following decades of research.

Having recently completed an $85m Series C fundraise, we are now entering a growth phase, where we are scaling our team as we take the Osler Origin product through regulatory activities, and towards market launch.

Join us and help build a better future.

 

About the role 

You will be responsible for helping define the product quality requirements for a new medical device platform, transferring the product to production and subsequently ensuring compliance to those standards through the product lifecycle. Confirming the product is safe, reliable, meets regulatory requirements and customer expectations.

Initially this role will work closely with cross functional development teams, to provide the quality and technical expertise to successfully transfer a new product platform (chemistry and cartridge) to a production state with a bias towards laboratory-based processes.

Applying your expertise and Quality Engineering (QE) experience you will help drive the successful technical transfer of the product, ensuring the product and documentation conforms to the quality and regulatory standards required.

The role will expand to the full life cycle of the platform encompassing the maintenance and continuous improvement of the platform, the on-market scale up to high volume and subsequent ongoing pipeline development programs.

As a Quality Engineer, you will be hands on, operating within work packages, executing project activities, and resolving quality issues, while also acting as a subject matter expert, offering your specialist support and guidance when called upon by team members from the wider organisation.

Operating through a matrix structure model, and at the coalface of project activities, you will be expected to champion quality issues by promoting a culture of high performance, continuous improvement, and regulatory compliance. This will be achieved while considering production efficiency and cost effectiveness.

Main responsibilities: 

  • Foster a workplace culture that prioritises the health, safety, and well-being of its employees, demonstrating a commitment to communicating, improving, and adhering to safety policies
  • Challenge and/or escalate non-conformance or contrary behaviours where known
  • Contribute at key programme and design and development reviews, as required representing the Quality Engineering discipline
  • Input into the sequencing of project activities and validation approaches to ensure robust quality assurance
  • Help define, develop, and validate the test methods needed to meet the control scheme
  • Facilitate risk management activities (PFMEA) to progress and report on resulting actions
  • Work collaboratively on test design (hypothesis testing / Design of Experiments (DOEs)) to inform technical decisions / direction
  • Help develop and support the execution of validation protocols for new tools, equipment, and processes, ensuring focussed tests establish, with confidence, key operating ranges, and capabilities
  • Implement the subsequent monitoring of processes using statistical process control methods
  • Support development of SOP’s / work instructions and training where required
  • Establish and report on key product and process quality metrics for production
  • Support NCR related investigations and activities, working collaboratively with other functional areas to investigate and resolve product and process quality issues, deploying appropriate tools to assist root cause analysis
  • Provide confidence in the manufacturing processes to meet quality requirements and customer expectations
  • Proactively develop, maintain, and leverage collaborative, cross-functional relationships (Product Development, Manufacturing Engineering, Quality, Supply Chain, Production, Facilities) and external networks/relationships in support of own, and wider, business deliverables
  • Act as a quality coach and mentor to colleagues improving knowledge, competence, and capability, of individuals and teams
  • Actively promote the creation of a work environment, supported by leadership, which fosters openness, trust, communication, teamwork, empowerment, innovation, and satisfaction

 

 

 

Skills, Experience, & Attributes 

Essential

  • Experience and expertise in the transfer and validation of products in highly regulated industries
  • Strong analytical skillset with the ability to identify risks to product, process performance and compliance
  • Proven ability in problem solving using established tools and methodologies
  • Practical understanding of verification and validation principles
  • Experience in applying appropriate statistical methods – hypothesis testing, Measurement System Analysis, Design of Experiments, Statistical Process Control
  • Strong communicator who leverages well-developed interpersonal, influencing and networking skills to build effective relationships, influence decision making, and drive outcomes
  • Strong verbal and written communications capabilities
  • Strong organisational, planning, and follow-up skills and ability to hold others accountable
  • Multi-tasks, prioritises, and meets deadlines in timely manner
  • Driven and resilient, with the ability to work effectively within a fast-paced changing environment while continually growing and developing own self
  • Experience transferring Laboratory based processes in ISO13485 or highly regulated sectors

Preferred

  • Degree (or equivalent working experience) in relevant engineering discipline
  • Formally trained and practising in Lean/Six Sigma philosophies and tool kits

Benefits

We offer a competitive benefits package, with a focus on health and well-being - further supporting the belief in our mission to enable anyone, anywhere, to access, understand and act on their health.

  • 25 days holiday + bank holidays and a Christmas closure
  • Annual Learning & Development budget 4% of your salary
  • 12 days of Learning leave
  • 4% matched pension
  • £500 Well-being allowance
  • Private Medical Insurance - (includes subsidised gym memberships)
  • 24/7 access to a GP
  • Life Assurance - x4 annual salary
  • Income Protection - 75% of your basic annual salary
  • Private Travel Insurance
  • Annual eye tests
  • Cycle to work scheme
  • Travel to work loan scheme
  • Relocation assistance
  • Volunteering leave
  • Give as you earn - pre-tax salary donations to any UK charitable organisation
  • Quarterly Team Building events and social events
  • Enhanced maternity/paternity

Join us and build a better future.