- Professional
- Optionales Büro in Oxford
Want to be part of a team transforming healthcare?
We are looking for an experienced Product Quality Engineer to join our team. Working within the Quality & Regulatory Affairs department, you will plan, coordinate, and manage quality assurance and quality control activities associated with product development, product manufacturing and post-product release to ensure internal and external compliance.
We are looking for an experienced Product Quality Engineer to join our team. Working within the Quality & Regulatory Affairs department, you will plan, coordinate, and manage quality assurance and quality control activities associated with product development, product manufacturing and post-product release to ensure internal and external compliance.
This is an exciting role for the right candidate as you will be responsible for defining and developing DHF deliverables. You will also oversee, review and conduct Design and Development File Verification and Validation at the end of each design control phase. You will provide quality control support for Adaptix outsourced manufacturing and own product-relevant NCR and CAPA processes.
You will work with colleagues across the business to provide clear, consistent, pragmatic and timely guidance as it relates to compliance exposure and provide innovative solutions to effectively resolve investigations and meet the needs of customers, regulatory bodies and wider strategic aims.
The Company
The Company
Medical imaging helps patients by enabling early and accurate diagnosis. However, 2D X-rays can be inconclusive as they give a fundamentally limited view of our 3D bodies. 3D images are possible with CT scanners but these are much expensive, give a high dose of radiation and moving a critically ill patient to a scanner can be labour-intensive and risky.
At Adaptix we are helping make 3D imaging more accessible to the people who need it by producing mobile, low dose systems that can be brought to patients and deliver imaging at point-of-care.
Candidate Profile
As our ideal candidate you have a minimum qualification a degree in Science or Engineering, together with a recognised Quality Management qualification, or equivalent experience.
Candidate Profile
As our ideal candidate you have a minimum qualification a degree in Science or Engineering, together with a recognised Quality Management qualification, or equivalent experience.
Key Responsibilities
Main duties and responsibilities:
- Provide focused quality engineering leadership, guidance and training and assume responsibility for timely and effective coordination and/or execution of assigned project activities for Adaptix medical, veterinary and non-destructive testing systems.
- Work with colleagues to ensure that all applicable elements and product technical standards are effectively incorporated into new designs and into design changes (change assessments for up to Class IIb CE and Class II FDA medical devices).
- Provide input to design and manufacturing documentation (material specifications, drawings, inspection procedures, and manufacturing procedures) to ensure products can be adequately manufactured and tested.
- Support the R&D team with Verification and Validation activities, including internal and external testing.
- Contribute to design input requirements, applying learning from previously reported problems (non-conforming material reports, yield, rework) or external sources (customer complaints, competitive devices / similar products).
- Lead and support Risk Management activities for new and/or modified products and processes, ensuring risk assessment occurs in the appropriate project phase, authoring risk management plans and reports, and facilitating risk assessment activities.
- Review and approve or reject technical transfer plans and reports from a design transfer perspective.
- Represent the Quality team in supplier selection process and component specification reviews to ensure purchased and proposed items meet specifications.
- Develop and validate quality test methods.
- Support quality system development and implementation throughout the product life cycle.
- Identify opportunities for continuous improvement and work with colleagues to support and implement quality and engineering changes.
- Generate internal quality documentation (e.g. quality plans, SOPs, work instructions and inspection procedures).
- Own the non-conformance processes, related to product development / product quality.
- Support colleagues with internal audits and risk assessments, taking corrective actions where necessary.
- Work collaboratively to implement Product Quality practices and procedures compliant with relevant standards including ISO 13485:2016, 21 CFR 820 (and transition to QMSR) and CE Marking/510k for medical devices.
Skills, Knowledge and Expertise
Skills:
- Solid knowledge across engineering, new product development and manufacturing disciplines, ideally in active electromedical devices incorporating software.
- Ability to provide quality engineering advice in a professional, credible manner.
- Ability to interpret product safety and other regulatory standards, including medical device cybersecurity.
- Excellent planning skills with the ability to manage concurrent projects and adapt to changing priorities. Maintains a high level of performance and remains calm when facing pressure and uncertainty.
- Effective communication of technical requirements both verbally and in writing.
- Ability to problem-solve, analyse data, spot trends, identify and document issues, with the confidence to suggest and implement agreed process improvements.
- Builds effective internal and external relationships, working effectively both independently and collaboratively.
Experience:
- Implementing Lean/Six Sigma principles, or equivalent manufacturing/business optimisation processes.
- Working in a Engineering / Quality role within highly regulated industries with process-driven environments.
- ISO / medical device-related standards, including software and cybersecurity.
- Experienced in using quality tools and statistical programs such as Minitab, risk assessment (FMEA), experimental design (DOE) and process improvement (SPC).
Apply Now
This is a permanent full-time role based at our sites in Begbroke and Eynsham, Oxfordshire. Compensation is competitive and commensurate with experience.
Please note the closing date, however should we find a suitable candidate before this date, the position may be filled earlier. Please note that we are unable to provide sponsorship for visa applications for this role.
If you feel that you would excel in this role we would be delighted to hear from you!
If you feel that you would excel in this role we would be delighted to hear from you!
