Senior Quality Engineer, Production

Job Title: Senior Quality Engineer

Employment Status: Full Time, Perm

Practice: NPI

Location: Oxford

Salary: Competitive

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:

• This role 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. 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.
• The role is envisaged to be hands on, working within work packages executing project activities and resolving quality issues, while also acting as a subject matter expert (SME). As SME, 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:

• In all areas within own remit, 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.
• Facilitate and contribute to risk management processes.
• Progress and report on resulting QE actions.
• Develop, with appropriate team input, the quality requirements and deliverables needed to deliver work packages.
• Collaborate and drive best practice and consistency across project teams.
• Work collaboratively on test design (hypothesis testing / Design of Experiments (DOEs)) to inform technical decisions / direction.
• Translate critical to quality requirements into an effective, coherent, documented production control scheme that ensures product safety and performance.
• Help develop and validate the test methods needed to meet the control scheme.
• 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 CAPA and 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.
• Help establish a complaints process and support any ongoing investigations and resolutions.
• Defend production controls and ongoing monitoring processes during audits and regulatory inspections.
• 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 key Point of Contact for other functions across the business, supporting Design for X, engineering change control, scale up and productivity initiatives, risk mitigations and 3rd party partnering.
• 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:

• Time served Senior Quality Engineer with extensive 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 to identify, assess, and solve complex problems using established tools and methodologies.
• Strong practical understanding of verification and validation principles.
• Proficient in applying appropriate statistical methods – hypothesis testing, Measurement System Analysis, Design of Experiments, Statistical Process Control.
• Command of risk management.
• Excellent 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 of working in MedTech or ISO13485 or highly regulated sectors.

Desirable:

• Degree (or equivalent) in relevant engineering discipline.
• Quality engineering certification.
• Formally trained and practising in Lean/Six Sigma philosophies and tool kits.
• Strong MS Office skillset.

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.

There is no perfect candidate, and no single person can do it all, but if this sounds like you, or what you could be and you're looking for somewhere to thrive; we want to hear from you.

We look forward to receiving your application. If you have any questions, please contact talent@oslerdiagnostics.com