Quality System Specialist

2 weeks ago

Oxford, United Kingdom Osler Diagnostics Full time

**Quality System Specialist**

**Location**: Oxford (4 Day in Office, 1 days WFH)

**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**

The Quality Systems Specialist will work as part our quality assurance and compliance team, supporting core quality management activities across the business to maintain compliance to medical device product development and manufacturing standards.

You will play a key role in ensuring our ISO 13485 quality management system is established, implemented, maintained, monitored, and continuously improved. This includes having responsibility for specific processes, procedures and protocols required for the design, development, and production of Osler's medical device products.

The Quality Systems Specialist will provide expert guidance and support to ensure processes, procedure and protocols are effective, compliant and user friendly and will work closely with the stakeholders throughout the Osler team to ensure this.

Osler is committed to quality and as part of our growing Quality Assurance team, you will play a key role in driving and developing our quality culture, helping people to understand what is needed, why and how best to achieve it through exceptional quality management.

This is a great opportunity to work in a new company with lots of potential to shape the QMS and quality culture.

**Main responsibilities**:

- Manage and coordinate document control and training activities via the electronic QMS (eQMS).
- Contribute to the creation and preparation of documentation; Manage the review and approval of documents, including SOPs, WIs and to ensure compliance to Good Documentation Practices, regulatory standards, and Osler's operating requirements.
- Provide support to users of the eQMS, assisting with initiating change requests and uploading associated documentation.
- Support the delivery of the Internal Audits, Non-conformance and CAPA management system in the business.
- Coordinate, review and approve change requests.
- Identify and own opportunities for continuous improvement across the Quality Management System.
- Perform QMS Gap Analysis resulting from changes in regulations and standards and continually monitor our internal procedures, processes and SOPs to ensure appropriate reviews and approvals have taken place.
- Prepare monthly quality key performance indicators.
- Being a quality ambassador throughout Osler.
- Working as part of a multidisciplinary team.
- Supporting extension to ISO Scope to include manufacturing of medical devices.
- Supporting notified body and external audits.

**Skills & Experience**

Essential
- Experience of working in a quality assurance role within FDA and EU regulated QMS frameworks for medical device design, development, and manufacture, specificallISO 13485 and / or ISO 9001.
- Exceptional verbal and written communication in English, able to clearly articulate and translate quality requirements to multidisciplinary teams.
- Be enthusiastic, positive, confident in communication.
- Excellent at translating standards into best practice.
- Have a pragmatic, flexible, solutions-oriented approach.

Desirable:

- Qualified auditor to BSI standard (or equivalent).
- Experience of participating in and supporting regulatory audits.
- Working in a start-up environment or small business as well as ones with more established QMSs.
- Experience in medical device, biotech or similarly regulated industries.

**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)

  • System Specialist

    2 weeks ago

    Oxford, United Kingdom Hays Specialist Recruitment Limited Remote Work Freelance Full time

    Hays are delighted to be working with our global client, one of the world's most successful premium manufacturers of cars, motorcycles, and provider of premium services. Our client demonstrates a commitment to innovation, sustainability, and product responsibility all the way from development to production. Their aim is to play a dynamic and innovative role...

  • Quality Specialist

    6 days ago

    Oxford, United Kingdom CM Medical Recruitment Full time

    Job Title: Quality SpecialistnLocation:Oxford (On-Site)Company Overview:nCM Medical have partnered with a pioneering wearable device start-up based in Oxford. We're transforming healthcare with innovative solutions empowering individuals and their health.nOur client are seeking a Quality Specialist to ensure the quality and compliance of our...

  • Quality Specialists

    3 weeks ago

    Oxford, United Kingdom CM Medical Recruitment Full time

    Job Title: Quality SpecialistIf the following job requirements and experience match your skills, please ensure you apply promptly.Location: Oxford (On-Site)Company Overview:CM Medical have partnered with a pioneering wearable device start-up based in Oxford. We're transforming healthcare with innovative solutions empowering individuals and their health. Our...

  • Quality Specialists

    3 weeks ago

    Oxford, United Kingdom CM Medical Recruitment Full time

    Job Title: Quality SpecialistLocation: Oxford (On-Site)Company Overview: CM Medical have partnered with a pioneering wearable device start-up based in Oxford. We're transforming healthcare with innovative solutions empowering individuals and their health. Our client are seeking a Quality Specialist to ensure the quality and compliance of our...

  • Quality Assurance Specialist

    1 month ago

    Oxford, United Kingdom WALKER COLE INTERNATIONAL LTD Full time

    Walker Cole International is searching for a **Quality Assurance Specialist**to join a pharmaceutical company in the South of England: Your Responsibilities as a**Quality Assurance Specialist** will include: - Participate in the improvement and maintenance of the eQMS - Support the implementation and management of quality systems from a CSV standpoint -...

  • Quality Assurance Specialist

    2 months ago

    Oxford, United Kingdom Bond Williams Full time

    Other responsibilities as Quality Assurance Specialist include: - Provide support to new product development activities and processes - Review and approve Design and Development documentation - Review and approve Change Control documentation for Quality Assurance - Support the maintenance of Quality System documentation - Analyse and communicate proposed,...

  • Quality Specialist

    15 hours ago

    Oxford, England, United Kingdom CM Medical Recruitment Full time

    Job Title: Quality SpecialistIf you think you are the right match for the following opportunity, apply after reading the complete description.Location:Oxford (On-Site)Company Overview:CM Medical have partnered with a pioneering wearable device start-up based in Oxford. We're transforming healthcare with innovative solutions empowering individuals and their...

  • Quality Specialist

    2 weeks ago

    Oxford, Oxfordshire, United Kingdom CM Medical Recruitment Full time

    Job Title: Quality Specialist If the following job requirements and experience match your skills, please ensure you apply promptly. Location: Oxford (On-Site) Company Overview: CM Medical have partnered with a pioneering wearable device start-up based in Oxford. We're transforming healthcare with innovative solutions empowering individuals and their...

  • Quality Specialist

    2 weeks ago

    Oxford, Oxfordshire, United Kingdom CM Medical Recruitment Full time

    Job Title: Quality Specialist If the following job requirements and experience match your skills, please ensure you apply promptly. Location: Oxford (On-Site) Company Overview: CM Medical have partnered with a pioneering wearable device start-up based in Oxford. We're transforming healthcare with innovative solutions empowering individuals and their...

  • Quality Assurance Specialist

    6 days ago

    Oxford, United Kingdom Oxford Nanopore Technologies Full time

    Oxford Nanopore Technologies is headquartered at the Oxford Science Park outside Oxford, UK, with satellite offices and a commercial presence in many global locations across the US, APAC and Europe. Oxford Nanopore's sequencing platform is the only technology that offers real-time analysis, in fully scalable formats from pocket to population scale, that can...

  • Quality Project Specialist

    2 weeks ago

    Oxford, Oxfordshire, United Kingdom CM Medical Recruitment Full time

    Job Title: Quality Specialist CM Medical have partnered with a pioneering wearable device start-up based in Oxford. We're transforming healthcare with innovative solutions empowering individuals and their health. Our client are seeking a Quality Specialist to ensure the quality and compliance of our products. Position Overview: As a Quality Specialist,...

  • Quality Project Specialist

    2 weeks ago

    Oxford, Oxfordshire, United Kingdom CM Medical Recruitment Full time

    Job Title: Quality Specialist CM Medical have partnered with a pioneering wearable device start-up based in Oxford. We're transforming healthcare with innovative solutions empowering individuals and their health. Our client are seeking a Quality Specialist to ensure the quality and compliance of our products. Position Overview: As a Quality Specialist,...

  • Quality & Regulatory Specialist

    7 days ago

    Oxford, United Kingdom Tec Partners Full time

    TEC Partners is pleased to have partnered with a pioneering medical device company who is set to pave the way for AI-based automated analysis software to overcome a global crisis affecting millions of lives. Quality and Regulatory Specialist As the Quality and Regulatory Specialist, you will play a pivotal role in my client's mission to deliver...

  • Quality & Regulatory Specialist

    6 days ago

    Oxford, United Kingdom Tec Partners Full time

    TEC Partners is pleased to have partnered with a pioneering medical device company who is set to pave the way for AI-based automated analysis software to overcome a global crisis affecting millions of lives.Quality and Regulatory SpecialistAs the Quality and Regulatory Specialist, you will play a pivotal role in my client's mission to deliver groundbreaking...

  • Quality & Regulatory Specialist (Permanent)

    5 days ago

    Oxford, United Kingdom Tec Partners Full time

    TEC Partners is pleased to have partnered with a pioneering medical device company who is set to pave the way for AI-based automated analysis software to overcome a global crisis affecting millions of lives.Quality and Regulatory SpecialistAs the Quality and Regulatory Specialist, you will play a pivotal role in my client's mission to deliver groundbreaking...

  • Quality & Regulatory Specialist

    5 days ago

    Oxford, Oxfordshire, United Kingdom Tec Partners Full time

    TEC Partners is pleased to have partnered with a pioneering medical device company who is set to pave the way for AI-based automated analysis software to overcome a global crisis affecting millions of lives. Quality and Regulatory Specialist As the Quality and Regulatory Specialist, you will play a pivotal role in my client's mission to deliver...

  • Specialist Systems Engineer

    2 weeks ago

    Oxford, United Kingdom D-Orbit Full time

    Are you ready to take your career to new heights? At D-Orbit, we're pioneering the future of space logistics and transportation. Established in 2011, our company is leading the way in helping businesses profitably and sustainably unlock the full potential of the final frontier. As a member of our team, you'll have the opportunity to work alongside a diverse...

  • Quality Engineer

    7 days ago

    Oxford, United Kingdom Cubiq Recruitment Full time

    Quality Engineer Apply promptly! A high volume of applicants is expected for the role as detailed below, do not wait to send your CV.Location: OxfordJob Type: PermanentSalary: Up to £50,000 DoE + Bonus Industry: First Tier Automotive What we can offer youBonus Scheme, Company Car Scheme, Private Medical Cover, Career progression opportunities About the...

  • Marketing Communications

    3 days ago

    Oxford, United Kingdom System C Full time

    We are System C, a proud British business on a mission to connect and transform health and care outcomes for all through our market leading software. We care about what we do, and that goes for our team members too. We take our role in public digital transformation seriously. We're in it for the long haul and pride ourselves on how we strive to be better,...

  • Quality/Regulatory Specialist, Medical Devices

    5 days ago

    Oxford, United Kingdom Tec Partners Full time

    TEC Partners is pleased to have partnered with a pioneering medical device company who is set to pave the way for AI-based automated analysis software to overcome a global crisis affecting millions of lives.Quality and Regulatory SpecialistAs the Quality and Regulatory Specialist, you will play a pivotal role in my client's mission to deliver groundbreaking...