R&D Quality Engineer / Lead (Medical Devices) job opportunity at Novanta.

Home Jobs In Czechia Tag: Job R&D Quality Engineer / Lead (Medical Devices) position at Novanta


DateMore Than 30 Days Ago bot
Novanta R&D Quality Engineer / Lead (Medical Devices)
Experience: 5-years
Pattern: full-time
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loacation Brno, Czechia
loacation Brno....Czechia

Build a career powered by innovations that matter!  At Novanta, our innovations power technology products that are transforming healthcare and advanced manufacturing—improving productivity, enhancing people’s lives and redefining what’s possible.  We create for our global customers engineered components and sub-systems that deliver extreme precision and performance for a range of mission-critical applications—from minimally invasive surgery to robotics to 3D metal printing. Novanta is one global team with over 26 offices located in The Americas, Europe and Asia-Pacific.  Looking for a great place to work?  You have found it with a culture that embraces teamwork, collaboration and empowerment.  Come explore Novanta. JOIN US and GET A 100.000,- CZK SIGN-ON BONUS! As our new  Team Lead for R&D Quality Engineers (m/f/d ) you will be leading a small local Design/Quality Assurance team in Brno. As a local team manager and as a Design Assurance Engineer you will be responsible for the creation of an overall quality plan, review of design verification and validation specifications, test specifications and reports for medical devices (devices and consumables), Review of Design Control documents according to GDP, MDR 2017/CFR820 and leading/contributing to risk management, FMEA and other quality (assurance) related tasks within product development. Your tasks: Lead a small local Design Assurance team in Brno on local people manager tasks. Creation of overall quality plan including document plan and overall VnV Plan. Creation and review of  design verification  and  validation  plans for medical devices (devices and consumables). Review of  Design Control  documents according to GLP, GDP, CFR820. As member of risk management team according to ISO 14971: Checking the systematics and completeness of the risk analysis Evaluation of risk-reducing measures Effects on the severity of damage and the probability of occurrence Checking the evidence for the implementation and effectiveness of the measures Member of Product/Design FMEA team. In cooperation with Quality Assurance: Participation in the creation of test specifications for series testing of medical devices Management, adjustment or maintenance of the calibration of measuring equipment. Failure analysis of failed units. Initiation and active participation in measures for synchronization and improvement of processes. Methodical support and conduction of NC/CAPA according to  ISO 13485. Strict compliance with quality, occupational safety and environmental regulations and implementation of instructions by quality/environmental management officers and the specialist for occupational safety. Your profile: Completed technical and/or physical university studies and 3-5 years of professional experience. Experience with quality design/assurance within R&D engineering. Experience with the topic of product quality in a highly regulated industry. Experience within medical technologies or devices is a must. Knowledge of ISO 13485 or MDR is highly preferred. Experience as a team lead or manager is a big plus. Familiarity with system testing, reliability testing and/or software/hardware testing. Knowledge and application experience in quality and statistical methods. Quality-conscious, trustworthy and reliable. Structured and systematic way of working. Good communication skills. English language skills required (B2-CEFR). Czech language skills are highly preferred (or work experience in Czech republic) Willingness to travel, mostly to Berlin (cca 10 %) Benefits: Extra week of vacation (25 days/year) 5 sick days per calendar year 1 day of paid time off for charitable activities/year Flexi Pass vouchers with a nominal value of 1000 CZK/month Contribution to supplementary pension insurance 1000 CZK/month (after the probationary period) Flexible working hours (core 10 – 15:00) Every year, wages are reassessed from 1 April Meal vouchers in the form of a flat rate – monetary value (123,90 CZK/day) Monetary allowance for working from home (max. 2 days/week) MultiSport for only 300 CZK/month Bonuses for recommending a new employee up to CZK 110,000 Free refreshments at the workplace (juice, hot drinks – coffee, tea; healthy snacks and fruit/vegetables 2 times a week) Training, language courses, career advancement Dog-friendly office, Family-friendly environment Corporate events – Summer Party, Christmas Party, Family Day, SportDay, Board Game Afternoon, Meet & Greet and more Free parking for employees and shower at the workplace for athletes #LI-JM1 #LI-Hybrid Novanta is proud to be an equal employment opportunity and affirmative action workplace. We consider all qualified applicants without regard to race, color, religion, sex (including pregnancy), sexual orientation, gender identity or expression, national origin, military and veteran status, disability, genetics, or any other category protected by federal law or Novanta policy. Please call +1 781-266-5700 if you need a disability accommodation for any part of the employment process.

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