
SHL Medical AB · Nacka
Som Quality Engineer ansvarar du för att säkerställa att medicintekniska produkter och processer uppfyller regulatoriska krav genom hela livscykeln, från utveckling till produktion.
Som Quality Engineer ansvarar du för att säkerställa att medicintekniska produkter och processer uppfyller regulatoriska krav genom hela livscykeln, från utveckling till produktion.
SHL Medical is a world-leading provider in the design, development, and manufacturing of advanced self-injection devices. With a global team of 6,000 employees, we partner with leading pharmaceutical and biotech companies to deliver innovative autoinjectors, pen injectors, and other drug delivery systems that ensure effective treatment for patients. Headquartered in Switzerland since 2018, with key operations in Sweden, Taiwan, and the US, we are united by a commitment to innovation, impact, and growth. Together, we empower our people to develop solutions that make a meaningful difference in the lives of millions of patients while fostering a supportive, inclusive, and dynamic workplace for our colleagues.
Job Overview
The Sr Quality Engineer is responsible for acting as Workstream Lead Quality (QE Lead) in the Design & Development projects as responsible for design assurance activities across all project phases ensuring quality and robustness of the product design and manufacturing processes (including product care projects, design changes and design reviews).
Furthermore, the Quality representative is responsible to assure compliance with applicable regulations and SHL Medical AB’s Quality Management System (QMS) in both Design & Development Projects and other Quality element tasks such as CAPAs and Change Control handling.
Main Responsibilities
Maintain and calibrate laboratory equipment and instruments to ensure operational reliability and compliance.
To act as Workstream Lead Quality applying Quality Engineering principles in a dynamic way in development and production projects.
To represent Workstream Lead Quality in all Design Controls and Product Development related aspects.
To ensure that all design control and production/process control projects meet applicable (local and international) regulations, Corporate, Customer, and Local QMS requirements.
To utilize Quality Engineering best practices, ensuring internal and external customers’ needs and requirements are built into new products and future product changes.
To support SMEs in the identification and traceability of Critical to Quality attributes by applying Advanced Product Quality Planning/DFSS/Risk tools and techniques across all product development phases. To promote the use of statistics in testing and control of quality.
To support and guide Risk Management activities (FMEAs). To assess and approve the risk mitigation techniques implemented and whether these are consistent with the product classification, potential defect types, defect frequency, severity, patient risk, process capability, product and process controls.
To support Device product/process development and production activities, including the following:
Develop or review product/process specifications and requirements.
Develop or review product reliability specifications/predictions, and reliability test activities.
To develop quality plans and work further with Manufacturing on the transfer of quality requirements.
To contribute to compilation and maintenance of Design History Files (DHF).
Minimum requirements
Minimum 5+ years' work experience in relevant roles such as Quality Assurance, Quality Engineering
Fluent in written and spoken English.
Experience from working with interpretation of ISO Standards, e.g EN ISO 14971:2019 and EN ISO 13485:2016
Experience in establishing, reviewing and approving quality documentation
Experience with model development, test method validation and statistical analysis.
Green Belt practitioner, or demonstrated experience in application of Quality Methodologies such as DFSS, DMAIC, Lean
Hands-on experience in product development from ideation to launch in the Medical Device Industry
Preferred Qualifications
Fluent in written and spoken Swedish.
Experience with Design Controls and Design Transfer activities within the Medical Device industry
Experience with injection molding and automated assembly manufacturing processes.
Familiarity with validation activities including IQ/OQ/PQ and Test Method Validation (TMV).
Experience working in cross-functional and international environments.
We Offer
Challenging assignments in a fast-growing and innovative industry.
An exciting opportunity in a fast-growing international medical technology company.
A modern working environment with multicultural and dynamic teams.
A centrally located office in Zug, very close to the train station.
Interested in joining SHL Medical and in supporting us with your expertise and personality? Then we look forward to receiving your application to our Talent Acquisition Department.
Please note: We do not accept applications from recruitment agencies for this position
About the position Join Mycronic’s Pattern Generators Division as a Quality Engineer in the Metrology and Process Control group (PMCD). In this role, you will work with process quality, Statistical Process Control, and process optimization for advanced mask manufacturing used in the display and semiconductor industries. You will work close to the cleanroom, process equipment, metrology results, and R&D projects. The work combines data analysis, hands-on cleanroom processing, process tuning, and improvement of process control methods. You will support both daily process stability and new product development, with a focus on making our processes more stable, capable, and repeatable. Key Responsibilities include but are not limited to: • Drive and maintain SPC and process control, including monitoring process stability, setting control limits, analyzing trends, and improving process capability. • Work hands-on in the cleanroom with wet chemical and RIE processes, including developing, chrome etching, cleaning, tuning, troubleshooting, and process optimization. • Run and support both automated and manual mask processing, including operating process tools, performing manual process steps, refilling chemicals, and following cleanroom and safety routines. • Plan, run, and evaluate experiments to support R&D activities, including novel product development, process robustness, cleanliness, cleaning performance, and defect reduction. • Analyze process and metrology data to find trends, deviations, root causes, and improvement opportunities. • Support investigations related to yield, process variation, etch performance, uniformity, repeatability, cleanliness, and equipment-related process effects. • Create and improve documentation such as work instructions, process specifications, control plans, test plans, and quality routines. • Work closely with colleagues in process development, metrology, product development, production, system engineering, and quality. Qualifications Are you ready to help shape the future with us? Mycronic is the right place for you if you are driven, curious, and motivated by solving technical problems. To succeed in this role, you need a structured and analytical way of working, combined with a strong interest in hands-on process work. You should enjoy working in a cleanroom environment and be comfortable moving between practical processing, statistical analysis, troubleshooting, and technical discussions. You take responsibility for your work, pay attention to details, and want to understand why a process behaves in a certain way. Because the role includes frequent collaboration with other engineers, you should be a strong team player who can explain technical findings clearly and help turn data into practical improvements. On top of this, you need: • MSc or higher in Nanotechnology, Microfabrication, Semiconductor Processing, Physics, Chemistry, Materials Science, Chemical Engineering or related technical fields. • Experience with process optimization for chrome etch processes. • Experience from cleanroom work, preferably within semiconductor, photomask, display, MEMS, microfabrication, or similar advanced manufacturing. • Experience with SPC, process control, process capability, trend analysis, and data-based problem solving. • Practical experience with wet chemical processing, such as developing, etching, cleaning, or similar chemical process steps. • Good understanding of process variation, repeatability, stability, contamination control, and how process parameters affect product quality. • Ability to analyze complex technical problems and turn data into conclusions, actions, and improvements. • Willingness and ability to work hands-on in a cleanroom, including chemical handling and manual processing. • Fluent English, both written and spoken. It is a merit if you have: • Experience with RIE process development, tuning, troubleshooting, or process control. • Experience from photomask, semiconductor, display, MEMS, or advanced lithography-related manufacturing. • Experience with DOE, process windows, control plans, FMEA, root-cause analysis, or other structured engineering methods. • Experience using metrology data to understand and improve process performance. • Experience with cleanliness, cleaning processes, particle control, contamination analysis, or defect reduction. • Knowledge of chrome, quartz, glass, resist, or other materials used in mask manufacturing. • Experience supporting R&D projects or transferring processes from development into stable operation. Place of employment: Headquarters in Täby, right outside Stockholm, Sweden Application deadline: 2026-07-23 Contact person: David Luthman, Group Manager, david.luthman@mycronic.com. How to apply: Submit your CV via our portal A culture of collaboration and personal growth At Mycronic, we love what we do, but most importantly who we do it with. Because to us the relationships we have with our customers and each other are the keys to success. Take part in the excitement of working with innovative people and global businesses who are elevating today’s standards in modern electronics. Share in the responsibility of bringing great ideas to life within an inclusive culture that not only promotes personal growth and embraces diversity but depends upon it. Here you are expected to have a voice and will be encouraged to get involved. It’s this very mindset that empowers our people to make a positive difference for a broad range of businesses, society and the planet – every day. https://www.mycronic.com/en/career/working-at-mycronic/
Quality Engineer to our client Are you an experienced quality engineer with a solid understanding of EU regulatory compliance and product certifications? We are now looking for a Quality Engineer for a consultancy assignment with an established international company with a strong digital presence and operations across multiple European markets. If you enjoy combining technical product knowledge with compliance work and supplier contact – this could be the assignment for you. About the assignment Our client is an international company with a strong market position, a broad product portfolio and operations in multiple countries. You will be responsible for quality assurance and product compliance for hard goods within a specific product category, with a focus on certifications and EU regulatory adherence. You will report to the QA & Compliance Manager and work closely with commercial teams, suppliers, logistics and internal stakeholders. Responsibilities Product compliance & certification Manage the certification process including validation of test reports and creation of Declaration of Conformity (DoC). Maintain documentation related to product compliance and EU regulations such as CE and EUDR. Quality assurance Identify root causes of quality issues, customer complaints and product-related claims. Manage product inspections and release goods for shipment. Ensure correct product labelling and creation of manuals and instructions. Product development & supplier contact Collaborate with commercial teams on new product developments through risk assessments, sample reviews and technical specification creation. Act as the main contact to suppliers regarding quality and compliance matters. Guidelines & internal support Maintain and update quality guidelines such as the Quality Manual when laws, standards or internal procedures change. Support internal teams with in-depth product knowledge on relevant standards, certifications and applicable processes. We are looking for someone who Is structured, analytical and detail-oriented with high professional integrity in supplier relations. You are self-organised, flexible and comfortable in an environment where processes and ways of working are continuously evolving. You have strong collaboration skills and are used to working cross-functionally with multiple internal and external stakeholders. Requirements & qualifications Degree in a relevant technical field such as Engineering, Product Development, Quality Management or Product Compliance – or equivalent experience Minimum 4–5 years of relevant experience within quality assurance, product compliance, certification or supplier quality management Experience with EU product compliance and applicable standards such as GPSR, REACH, RoHS, RED, Battery Regulation, WEEE, EUDR and PPWR Good knowledge of Microsoft Office (Excel, Word, PowerPoint) Strong problem-solving and analytical skills Strong cross-functional collaboration skills Meriting experience Experience from consumer products such as hard goods, electronics, PPE or other regulated product categories Experience with technical documentation, risk assessments and supplier quality processes Experience with Adobe Illustrator, Photoshop/InDesign or CAD software Location & scope Stockholm - 100% Application To apply for assignments via Jappa, you need to create a consultant profile on our platform and submit your application. By doing so, your profile will also become visible to other clients looking for commercial and specialist consultants for future assignments. Spend 10–15 minutes creating your profile today to be considered for exciting opportunities. We have replaced traditional recruitment with a smart marketplace, industry expertise, quality-assured processes and AI. The result is clearer matches, faster responses and happier consultants and clients alike. With Jappa, finding the right assignment is simple. We give you access to a wide range of opportunities within e-commerce and tech – from shorter freelance assignments to longer engagements and permanent roles. Jappa is a talent-as-a-service solution where you, as a consultant, are at the centre. We always strive to match you with assignments where you can truly make a difference and grow.
Här får du möjligheten att kliva in i ett innovativt deep-tech bolag där forskning, utveckling och produktion sker sida vid sida – och där kvalitet är en avgörande del av att lyckas. Du blir en del av ett litet och engagerat team där du får arbeta nära både produktion, utveckling och industrialisering i en verksamhet som fortfarande befinner sig i en spännande uppbyggnadsfas. Det här är inte en traditionell kvalitetsroll i en färdig organisation med tydliga ramar och långa beslutsvägar. Här händer det mycket, beslut fattas snabbt och arbetet präglas av nyfikenhet, samarbete och viljan att tillsammans bygga något långsiktigt. För rätt person innebär det en möjlighet att påverka på riktigt och vara med och forma både arbetssätt och framtida struktur. Om tjänsten Som Quality Engineer kommer du att arbeta brett med kvalitetsfrågor kopplade till både process, produktion och produktutveckling. Ena dagen analyserar du produktionsdata och identifierar trender eller rotorsaker bakom avvikelser, nästa dag sitter du tillsammans med utvecklingsteamet och diskuterar hur kvalitet ska säkras i nästa steg av industrialiseringen. Rollen innebär många kontaktytor och du kommer att arbeta nära både forskare, ingenjörer, produktion och ledning. Miljön är datadriven och kvalitetsteamet arbetar aktivt med statistik, SPC och analysverktyg för att förstå processer och driva förbättringar framåt. Samtidigt handlar rollen minst lika mycket om kommunikation och samarbete – att kunna få med sig andra, skapa förståelse för kvalitet och bidra med struktur utan att bygga onödig byråkrati. Du kommer bland annat att arbeta med: Dataanalys, trenduppföljning och statistisk processtyrning Rotorsaksanalyser och förbättringsarbete Kvalitetsverktyg såsom RCA, PFMEA och DFMEA Process- och produktkvalitet nära produktionen Kund- och leverantörsrelaterade kvalitetsfrågor Att vidareutveckla kvalitetsprocesser och arbetssätt i takt med att bolaget växer Vi tror att du Har några års erfarenhet inom kvalitetsarbete i tillverkande industri och trivs i en miljö där teknik, produktion och problemlösning står i centrum. Du har sannolikt arbetat nära processer och produktion tidigare och känner dig bekväm med att använda data för att förstå problem och driva förbättringar. Vi tror också att du: Har erfarenhet av SPC och statistisk analys Har arbetat med kvalitetsverktyg som RCA, PFMEA eller DFMEA Har förståelse för QMS och kvalitetsarbete i industrimiljö Har en teknisk utbildningsbakgrund, gärna inom produktion, material, kemi eller liknande område Trivs i en dynamisk miljö där inte allt är helt färdigdefinierat Det är meriterande om du har erfarenhet av analysverktyg som JMP eller Minitab samt om du tidigare arbetat inom processindustri, materialteknik eller annan högteknologisk tillverkningsmiljö. Stor vikt kommer läggas vid personlighet och vi tror att du är en nyfiken, prestigelös och samarbetsorienterad person som gillar att ta ansvar och bidra där det behövs. Här hjälps man åt, arbetar tätt tillsammans och bygger vidare på verksamheten som team. Om företaget Bolaget är ett svenskt teknikföretag i framkant inom material- och energiteknologi. Här kombineras forskning, utveckling och produktion i en innovativ miljö där nya idéer snabbt kan omsättas till verklighet. Kulturen präglas av öppenhet, högt engagemang och viljan att tillsammans lösa komplexa tekniska utmaningar. För dig som gillar teknik, förändring och möjligheten att påverka erbjuder detta en unik chans att bli en del av en verksamhet där man verkligen gör skillnad – varje dag. Om anställningen Detta är en rekrytering där du blir anställd direkt hos kundföretaget. Rekryteringsprocessen hanteras av Friday och alla frågor kring tjänsten hänvisas till ansvarig rekryterare. Övrig info Omfattning: HeltidStart: Enligt överenskommelsePlacering: Kista, StockholmArbetssätt: 100 % på plats, med viss flexibilitetLön: Fast månadslön Ansök genom att klicka på länken nedan. Urval sker löpande och tjänsten kan komma att tillsättas innan sista ansökningsdag. Om Friday: På Friday hjälper vi Tech-talanger att hitta roller där de trivs, utvecklas och gör skillnad. Genom att lyssna på vad just du vill och drivs av, matchar vi dig med företag och möjligheter som får dig att se fram emot att gå till jobbet. Vi värderar ambition och potential högt och arbetar aktivt för en fördomsfri rekrytering, där alla ges samma chans att lyckas. Vi finns i Stockholm, Göteborg, Malmö, Linköping och Örebro. Varje år genomför vi över 5 000 karriärmöten och matchar kandidater med allt från globala företag till innovativa startups. Sökord: Quality Assurance, QA, Quality engineer