Job title: Product Quality Engineer Salary Range: £30,000 to £35,000 Location: Kingswinford A Product Quality Engineer is required with auditing experience and strong problem solving skills. Candidates with experience of the medical industry would be well received. Due to growth this company, a leading supplier of disability products based in Kingswinford requires a proactive Product Quality Engineer for a new permanent role. As a Product Quality Engineer you will be responsible for: Management of the ISIR/PPAP and supplier capability processes for new and modified parts – proactively chasing for samples and resolving issues. Liaising with Central Purchasing with respect to initial supplier audits. Identifies, investigates and drives resolution of all product quality related issues. Supports PFMEA and DFMEA activities. Maintain the company’s Quality Management Systems ISO9001, ISO 13485 and FDA QSR requirements. Support implementation of ISO 13485. Internal process and QA auditing (Auditing the process and identifying where potential failure points are and recommending action to address in conjunction with the process owner) Cross UK site systems and audit support as required. Supporting and taking part in the Engineering change process (ECN and ECR) Root cause analysis of field and production failures (including organising or carrying out appropriate measurements and tests required and visiting site to lead and conduct full investigations Writing reports and presenting to customers the output of investigations Management of the 8D process for non-conforming supplier product Supplier visits to resolve supplied product quality problems Reporting and inputting into senior management KPI’s and Management review The Product Quality Engineer should have the following skills or experience: Auditing experience in any of ISO 9001, ISO 45001, ISO 14001 and ISO 13485 and FDA Part 820 Quality System Regulation – ideally lead auditor trained Degree educated in engineering discipline Knowledge of SPC/data analysis and ISIR/PPAP CMM Knowledge and the capability of reading engineering drawings is desirable 8D/Problem solving - Problem solving to root cause Excellent interpersonal skills at all business levels Good presentation and communication skills Good at prioritising and managing high workload IT Skills (Word/Excel as a minimum) ERP knowledge experience (Navision or Microsoft Dynamics AX and CRM) Experience of disability equipment or similar industry Demand for this role will undoubtedly be high and interviews will be arranged very soon. If you want to be considered, please apply today. If you have any questions about the Product Quality Engineer role, please contact Georgia Silk at Jonathan Lee Recruitment. Your CV will be forwarded to Jonathan Lee Recruitment, a leading engineering and manufacturing recruitment consultancy established in 1978. The services advertised by Jonathan Lee Recruitment are those of an Employment Agency.Permanent / Kingswinford
Job title: Quality and CI Engineer Salary Range: £35,000 to £40,000 Location: Kingswinford A Quality and CI Engineer is required with auditing experience and strong problem solving skills. Candidates with experience of the medical industry would be well received. Due to growth this company, a leading supplier of disability products based in Kingswinford requires a proactive Quality and CI Engineer for a new permanent role. As a Quality and CI Engineer you will be required to: Identify improvement activities, collection and analysis of data, identification of actions and execution of those actions. Review processes and available data sources for opportunities for improvement. Identify actions and drive them to completion either individually, as part of a team or as facilitator for other teams. Identify root causes of failures / complaints and issue the actions to address them through the NC and CAPA processes in a timely manner. Maintain the company’s Quality Management System ensuring compliance to ISO9001, ISO 13485 and FDA QSR requirements. Support implementation of ISO 13485. Internal process and QA auditing (Auditing the process and identifying where potential failure points are and recommending action to address in conjunction with the process owner) Cross UK site systems and audit support as required. Involvement in DFMEA and PFMEA activities Analysing, identifying and reporting on the top complaint and reliability issues, driving root cause and resolution of such issues with the operations and customer services teams Identifying and driving improvement in all operational activities (including within the supply chain) – using such techniques as 7 wastes, Kaizen etc Writing reports and presenting the output of investigations Reporting and inputting into senior management KPI’s and Management review The Quality and CI Engineer should have the following skills or experience: Auditing experience in any of ISO 9001, ISO 45001, ISO 14001 and ISO 13485 and FDA Part 820 Quality System Regulation – ideally lead auditor trained Knowledge of either ISO 9001, 13485 and FDA Part 820 Quality System Regulation Degree educated in engineering discipline Knowledge of SPC/Data analysis PFMEA/DFMEA, 8D/Problem solving and ISIR/PPAP Problem solving to root cause Good presentation/communication skills Good at prioritising and managing high workload Problem solving and root cause analysis skills CMM Knowledge and the ability to read engineering drawings is desirable IT Skills (Word/Excel as a minimum) QMS, H&S and EMS Experience (ISO 9001/ISO 18001 and ISO 14001) Experience in medical equipment or similar industry Understanding of NPD Processes Medical Device quality systems and their implementation Demand for this role will undoubtedly be high and interviews will be arranged very soon. If you want to be considered, please apply today. If you have any questions about the Quality and CI Engineer role, please contact Georgia Silk at Jonathan Lee Recruitment. Your CV will be forwarded to Jonathan Lee Recruitment, a leading engineering and manufacturing recruitment consultancy established in 1978. The services advertised by Jonathan Lee Recruitment are those of an Employment Agency.Permanent / Kingswinford
Job Title - Clinical Affairs Manager Daily rate - up to £400 Location - Malmesbury Industry - Medical Devices It is possible that this role will last beyond April 6th 2020, when reforms to IR35 tax legislation come into effect. As a result, the role will be assessed to determine if it falls inside or outside IR35. An exciting opportunity has arisen with an innovative forward thinking company for a Clinical Affairs Manager. As Clinical Affairs Manager, you will be "hands on" and fully involved in all aspects of clinical research for medical devices. The clinical affairs manager will be responsible for the entire lifecycle of all clinical projects, from concept and design through to regulatory submissions, implementation and reporting. The role includes the creation of clinical SOPs, and writing clinical protocols. Key Responsibilities of the Clinical Affairs Manager: Overall responsibility for setting the clinical strategy including clinical operations, with a focus on clinical investigations and evaluations for regulatory purposes and marketing trials. Responsible for interfacing with ethics committees and obtaining applicable ethics approval for proposed studies. Ensuring compliance with all relevant regulatory requirements in cooperation with Quality and Regulatory Affairs, the legal department and any relevant protocols set by the company. Develop budgets, forecast and planning schedules for the clinical affairs function. Provide adequate, maintained devices for clinical activities to meet the strategic goals of the Company. Work with Quality, Regulatory and Compliance departments to prepare documentation for submissions to obtain regulatory approval for commercialization of medical devices, supporting regulatory inspections/audits. Develop and implement clinical marketing plans, serving as a senior relationship manager and spokesperson in clinical marketing and outreach activities. Reviewing, obtaining and providing clinical input on content of device labelling and promotional material. Select and manage vendors to assist in necessary operational aspects of running clinicals as budget and resources permit. Lead the ongoing review of clinical trial data (as needed), analysis and interpretation including the development of first interpretable results, clinical investigation and evaluation reports, publications and internal/external presentations. Including post market follow up studies. In addition to the above, you will have a Science degree and proven experience in the medical device sector and a working knowledge of IVD Directives, MDR and IVDr regulations, and other relevant international standards and guidelines. You will also have experience of Quality Management Systems ISO 13485. You will have proven experience of managing clinical investigations and evaluations from planning, obtaining ethics committee approvals, implementation and successful completion. Medical writing and statistical analysis skills advantageous. Knowledge of consumer products beneficial. If you would like to know more about this role, please contact Sarah Gilbert at Jonathan Lee Recruitment. Your CV will be forwarded to Jonathan Lee Recruitment, a leading engineering and manufacturing recruitment consultancy established in 1978. The services advertised by Jonathan Lee Contracts are those of an Employment Business.Contract / Malmesbury
Strategic Procurement Manager(s) – Electronics / Mechanical Cambridge Attractive salary and benefits package Exciting opportunity for strategic procurement professionals to work for one of the UK’s most innovative technology development companies. This is a truly exceptional organisation who are at the forefront of a leading edge and growing, technology led medical device market. We are looking to recruit procurement professionals who have a passion for working with a creative and forward thinking environment. A track record of success within a technical procurement role and experience of bringing complex new products to market is key. As a Strategic Procurement Manager, you will lead a new and expanding strategic procurement team, responsible for managing a small team of buyers. Your technical commodity background should either be mechanical or electronic biased. With your technical and commercial skills, you will build strong relationships with key suppliers, as well as cross-functional teams. This is a pivotal role providing the link between internal and external stakeholders. A natural communicator hopefully goes without saying, but in addition you will have: Strong organisation and negotiation skills Degree qualified in a relevant discipline Additional professions qualifications highly desirable (CIPS) Experience of procurement within a similar, technology led and highly regulated industry. Proven track record of success in strategically managing electronics or mechanical related commodities. A good understanding of technical terms with respect to Mechanical and/or Electronic materials, to enable confident communication with suppliers and internal engineering Ability to lead and develop a small team of procurement professionals. Influence and negotiate with both internal and external stakeholders. Desire to contribute directly to a company who will revolutionise the healthcare/medical sector globally. A self-motivated and customer focused approach A flexible, responsive approach and mindset to work productively in a busy environment Proven decision-making experience A natural communicator hopefully goes without saying, but in addition we’d like you to have: In return for your extensive technical procurement skills and experience, you will be offered a competitive salary and a great benefits package (including non-contributory pension scheme, cycle-to-work scheme, life assurance, and our infamous monthly BBQs). On top of that, you’ll be joining a company with a fabulous culture of ambition, creativity and teamwork, and where fun is just as valued as our commitment to make surgery better for millions of people. Interested? If so, please forward your latest CV to firstname.lastname@example.org or call me to discuss 01384 446162. Your CV will be forwarded to Jonathan Lee Recruitment, a leading engineering and manufacturing recruitment consultancy established in 1978. The services advertised by Jonathan Lee Recruitment are those of an Employment Agency.Permanent / Cambridge
We have been more than encouraged by the work that Jonathan Lee Recruitment has completed for the members of the EEF, their marketplace knowledge across a wide variety of engineering sectors and most importantly the strong professional culture that they work to and high levels of service they provide. We would happily recommend the Jonathan Lee Recruitment business to any engineering and manufacturing organisation looking to engage a professional, committed and quality consultancy to support their recruitment activities.
I would like to thank Jonathan Lee Recruitment for the fantastic assistance given to me along my recruitment path to find employment. The communication was great via e-mail and telephone. The guidance you gave was second to none relating to my CV and experience. I received the perfect job description matches from your systems job alerts which I duly successfully applied to. Thank you Jonathan Lee Recruitment...the perfect team!
I would like to thank Jonathan Lee Recruitment for their patience and professionalism in helping me secure my new role. They supported me throughout my application and even coached me before my interviews. I even had good luck messages before my initial interview. They kept me well informed, returned all my calls and sought positive outcomes when required. I would not hesitate to recommend the team at Jonathan Lee Recruitment to anyone looking for a job.
I was contacted Jonathan Lee Recruitment, who guided me through the labyrinth of modern day recruitment. Keeping me fully informed and allaying my fears at every step of the process. Working with me to ensure I was fully prepared for every new encounter. The only company I found to give such a “full on” supporting role. Thanks to Jonathan Lee Recruitment. I was offered the role within 2 months of my initial application and will be continuing my career soon.
Since my first contact through to successfully securing a position via Jonathan Lee Recruitment, you have been really professional and understanding to my situation and tried to help me as much as possible. I have had a really good experience with Jonathan Lee Recruitment because of the work you have done on my behalf and I have no hesitation in recommending yourselves to my friends and colleagues. Thank You!