Location
Oxford
Closing date
20 Jan 2022

Adaptix is looking for a talented Product Development Quality Engineer to join its team. Working within the Quality & Regulatory Affairs department, you will plan, coordinate, and manage the quality assurance (QA) activities associated with one or multiple Product Development projects to ensure compliance to internal and external requirements during the development and commercialization of new products.

This is an exciting role for the right candidate as you will partner with Product Development teams to enable efficient, effective and rapid development and commercialisation of new products. You will provide clear, consistent and timely feedback as it relates to compliance exposure and will provide innovative solutions to effectively resolve investigations and to meet the needs of customers, regulatory bodies and business requirements.
 

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 flat-panel X-ray systems that can be brought to patients giving low-cost, low-dose imaging. 
 

Candidate Profile
 

As our ideal candidate you have a minimum qualification of HND in Engineering, together with a recognised Quality Management qualification, or equivalent experience. We would welcome applications from ISO 13485:2016 certified internal auditors.  

Key Responsibilities

Main duties and responsibilities

  • Provide focused quality engineering support and assume responsibility for timely and effective coordination and/or execution of assigned project activities.
  • Assure that all applicable elements and product technical standards are effectively incorporated into new designs and into changes to designs.
  • Provide input to design and manufacturing documentation including material specifications, drawings, inspection procedures, and manufacturing procedures.
  • Contribute to design input requirements from experience with previously reported problems from internal sources (non-conforming material reports, yield, rework) or external sources (customer complaints), competitive devices and/or other similar products.
  • Lead and/or support Risk Management activities for new and/or modified products and processes which includes ensuring that risk assessment occurs in the appropriate phase of the project, authoring risk management plans and reports, facilitating risk assessment activities with no guidance required. 
  • Review and approve/reject technical transfer plans and reports from the design transfer perspective. 
  • Participate in supplier selection process and component specification reviews to ensure that purchased items meet specifications.
  • Develop and validate quality test methods.
  • Act as an effective leader or team member in supporting quality disciplines, decisions, and practices to ensure continual improvement.
  • Support quality system development and implementation throughout product life cycle.
  • Generate internal quality documentation such as quality plans, standard operating procedures, work instructions and inspection procedures.
  • Supporting non-conformance, including CAPA processes.
  • Full involvement in internal audits and risk assessments, taking corrective actions where necessary.
  • Working with the QR Director and QR Manager to implement Product Quality practices and procedures compliant with relevant standards including ISO 13485:2016 and CE Marking for medical devices.

Skills Knowledge and Expertise

Skills 

  • Solid knowledge of engineering fundamentals and proven ability to apply this knowledge to new product development and manufacturing.
  • Aptitude for analysis, organisation and planning.
  • Detail focus with the tenacity to see tasks through to their successful completion.
  • Strong written and verbal communication skills with the ability to build positive relationships and communicate technical requirements. 
  • Ability to explore alternative options in order to address any unforeseeable blockers / address any issues in a pragmatic way.
  • Experienced in using quality tools and statistical programs like Minitab, risk assessment (FMEA), experimental design (DOE) and process improvement (SPC) is required.
  • Familiarity with small electromechanical machines and, ideally, X-ray equipment. 
  • A Lean/Six Sigma certification (desirable).

Experience

  • Hands-on experience in a Product Development or R&D Organisation showing increasing responsibility working in a highly regulated industry with a process-driven environment.
  • Demonstrated working knowledge of 21 CFR 820 (Quality Systems Medical Devices), ISO 13485, ISO 14971, and other medical device related standards.
  • Medical device product development leading to a regulatory submission (i.e. CE Marking)
  • Working with MRP/ERP experience (desirable)