Quality Engineer (production) - MedTech start up
We are looking for a highly skilled and ambitious Quality Engineer who can secure high-quality standards in our production of next-generation diagnostic devices for infectious diseases.
We are looking for a Quality Engineer who can strengthen the quality control of our manufacturing activities. Your job will be to focus on ensuring the quality of multiple products manufactured at BluSense in Copenhagen.
As an ideal candidate you will have in-depth knowledge about high-throughput manufacturing lines, quality controls, process development and validation, microfluidics assembly, biochemistry and reagents quality control and medical device regulations and standards (such as Directive 98/79/EC, IVDR and ISO 13485:2016).
You will work closely with our quality team to assist production in relation to all aspects of quality control for BluSense's point-of-care cartridges. Furthermore, you will work directly with quality assurance to facilitate manufacturing processes for improvement using various methods of testing and inspection. You will also be performing daily quality checks, incoming goods inspection, and sampling during production in a dynamic and challenging environment.
- Helping to create new documents for the QMS (e.g. work instructions, standard operating procedures or forms)
- Floor presence in all production areas to provide quality oversight for all critical manufacturing processes, executing regular quality inspections through the whole production cycle of our product and perform product release
- Performing activities related to QA oversight of manufacturing and guidance of manufacturing staff
- Performing inspection of final products, reviewing batch records and packaging records
- Performing control of incoming goods
- Assist when NC’s (Non-Conformances) occur in production, facilitate root cause analysis investigations in close cooperation with your colleagues and drive the entire NC handling process
- Complete regular inspections of the environmental conditions of the manufacturing areas and ensure that Good Manufacturing Practice is adhered to
- Supporting Validation and QA in process and equipment validation. Supporting QA with supplier management activities
- Assisting in audits (internal and external)
- Inspecting/Reviewing/Screening product and materials as part of QA investigation.
- Minimum Bachelor's degree in production engineering, science (biology, chemistry, medical technology) or medical fields
- Minimum 1-2 years' experience with Quality Assurance of Manufacturing within Medical device, preferably IVD or food industry
- Knowledge of ISO 13485:2016 is desirable
- Experience drafting, authoring and reviewing SOPs
- Ability to write clear and concise instructions and to carry out trainings
- Knowledge of A3 problem solving or 8D methodology is a plus.
- Fluency in English, both verbally and in writing
- Ability to make independent decision regarding quality related concerns or issues
- Ability to manage workload and adhere to timelines managing multiple conflicting priorities and deadlines
- Ability to work in an agile and fast-moving environment with cross-functional teams
- Ability to critically evaluate and troubleshoot complex problems together with colleagues and lead root cause analysis.
- Well-organized and detail oriented professional, with strong verbal and written communication skills
- Computer literate, competent in Excel, Word and Powerpoint.
- Work in a young, international and highly motivated team
- Have a leading role in bringing to market a novel point-of-care device
- Competitive salary.
How to apply
We will process applications as they arrive. Therefore, please submit your application and CV in one pdf file via "Apply online" as soon as possible and no later than June 21th, 2019. Qualified applicants can expect to be called for an interview ahead of the deadline.
We plan to hire for a job start in July/August 2019.
If you have any questions, please contact the hiring manager, QA Specialist Dermot O’Connor at Dermot.OConnor@blusense-diagnostics.com.