An exciting opportunity has arisen for a Senior Process Engineer with Medical Device experience to work for a leading Manufacturer based in the UK.
Your role will be to lead the development of internal quality control process's, primarily focusing on production quality control as well as regulatory and compliance activities and contributing to research and development of Fluidics, Mechanical Engineering, Hardware/ Embedded HW and SW. You will come from an IVD /biotechnology/ engineering background, with a passion for driving quality and process improvements.
This role, irrespective of other responsibilities, shall have authority over and responsibility for ensuring that quality system requirements are effectively established and effectively maintained in the Production area and as such will report on the performance of the quality system to the Head of Quality to whom they will have an indirect reporting line.
You will have experience in Quality tools and techniques such as Statistical Process Control, implementing Corrective and Preventative Actions, conducting Risk Assessments, FMEA and Root Cause Analysis. Experience with non-destructive methods of inspection and test and exposure to Kaizen would be an advantage.
You will also have experience of supplier quality management and in carrying out quality/supplier audits and be willing to assist in other regulatory and quality activities.
You will have the ability to supervise a small team of Quality Technicians/ Engineers and be able to demonstrate an ability to work within a high tempo team or work unsupervised for periods of time.
About the position:
- To establish, validate and implement procedures and protocols for incoming and in-process inspection of engineered components including microelectronics and microfluidic parts. This will include a variety of different measurement types, including optical, electrical, and chemical.
- To create and interrogate SPC charts, and perform data analysis (Such as DOE, ANOVA, MSA, Gage R&R) to validate new process, equipment, suppliers as well as the continual monitor of our internal processes.
- To oversee the control of the reference and retention samples of materials and products to ensure stability of products/processes.
- To generate and maintain inspection and quality control documentation in line with ISO13485 and GMP.
- Lead the investigation of quality issues, understanding component interaction, non-conformance procedures, driving to root cause, and implementing corrective and preventative actions, and post action verification.
- Working closely with interfacing departments on process validation, control, and procedural improvements from a quality control and assurance prospective
- Developing relationships, working with external suppliers and internal departments to improve overall end to end process quality and carry out and report on quality/supplier audits.
- Advising and training colleagues on aspects of quality management and working with the Process, and Quality Assurance teams to review and create QC process documentation.
- Working with the lab manager and process engineering department to ensure the calibration of and maintenance and where necessary validation (IQ, OQ, PQ) of a suite of production and lab equipment and instruments
- To assist with the creation of design and process FMEA's
- Report to manufacturing management with weekly quality and problem reports
Experience, Knowledge, & Skills
- Experience with metrology and measurement devices for QC (optical measurement machines, electrical, chemical testing)
- Relevant industrial experience working hands-on in a high-quality/high-volume/highly regulated manufacturing environment in Medical Devices, IVD or similar quality focussed field.
- Ability to work in a safe manner with experience following Health, Safety, and Environmental policies
- HNC/HND/Degree in quality, biotechnology, engineering or equivalent
- Strong systems thinking approach with the ability to "see the larger picture"
- Experience in conducting risk management evaluations, root cause analysis and leading Six Sigma projects is essential
- Strong analytical and problem-solving skills
- Proven experience using SPC and other data-analysis tools and software (Minitab ideally)
- Be a data-driven decision maker
- Sense of urgency - make things happen/get results
- Good understanding of ISO 9001, ISO 13485, ISO 14971, and requirements / regulations of the IVD industry.
- Trained auditor qualification preferred
- Experience in using ERP (ideally SAP)
- Capable of producing comprehensive technical reports
- Capable of working collaboratively with a range of internal and external stakeholders
To find out more about Real please visit www.realstaffing.com
Real Staffing, a trading division of SThree Partnership LLP is acting as an Employment Agency in relation to this vacancy| Registered office | 1st Floor, 75 King William Street, London, EC4N 7BE, United Kingdom | Partnership Number | OC387148 England and Wales