Senior Quality Engineer
Is quality improvement your passion? Do you put the customers at first? Do you want to make the difference in the Healthcare industry?
As the demand for high quality products and service increases, Varex Imaging takes process and product quality seriously and the role of Quality Assurance is important to its success.
As a Senior Quality Engineer, your responsibilities include the development, implementation and maintenance of our Quality Management System (QMS) within the organisation.
You will work with various disciplines to help improve the quality of our design, supply chain and manufacturing processes and associated documentation, traceability and services. This includes working on the reliability and continuity of processes to have leaner and more effective processes.The ultimate goal is to bring the quality of the entire organisation to the next level.
Audits and inspections
Supervise audits conducted by certifying institutions and customers, including the monitoring of the related follow-up actions. Carry out internal audits, line inspections and spot checks. Identify deviations and monitor the resulting corrective and preventive measures and verify their implementation. Make annual Quality plans.
Initiate, lead and supervise improvement projects related to Quality Management System, including process improvement initiatives according to, for example, (Lean) Six Sigma methodologies.
Collecting and analysing data
Perform measurements and analyse production, complaints and supplier data, which can lead to the improvement of processes in the organisation.
Handling of complaints and internal rejections
Manage Post Market Surveillance and Vigilance processes and related activities, including Risk Management actions. Initiate corrective and preventive measures for complaints and internal deviations. Supervise root cause analyses. Assess correct handling and resulting actions. Manage the NCM and CAPA database and close NCMs and CAPAs. Analyse NCMs and CAPAs for structural problems and initiates corresponding improvement actions.
Train colleagues withing the organization and be the ambassador of a proactive quality culture.
Knowledge & Experience:
- HBO, technical background, preferably mechanical and/or electrical engineering;
- Minimum of 5 years relevant work and experience in medical device, automotive, or pharma industry;
- Knowledge of ISO 9001:2015, ISO 13485:2016, 21 CFR820 and MDSAP. EU MDR is a plus;
- Experience with Quality Methods such as 8D, KAIZEN and PDCA; (Lean) Six Sigma methodologies (Green Belt or higher) is a plus;
- Post Market Surveillance knowledge and experience is a plus;
- Experience with change management, improvement processes, project management and scrum techniques including measurement methods tools (experience with Minitab is a plus);
- Fluent in spoken and written English;
- Basic knowledge of Dutch is preferable.
- Proactive, focus on details and on an “helicopter view”;
- Customer-, service- and result-oriented;
- Analytical ability and data driven;
- Patient and agile;
- Communicatively strong.
What does Varex Imaging have to offer you?
- A changing and growing organization with a high level of ambition;
- An environment that challenges you and offers new opportunities for your future development;
- Alternating and responsible work;
- A pleasant and enjoyable working atmosphere with an active staff association;
- Good training and development opportunities;
- Flexible working hours;
- Possibility to work from home;
- A competitive salary in line with your experience;
- An excellent primary and secondary employment conditions package;
- A convenient location within walking distance of public transport (bus and train) and close to the A18 motorway.