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As our new Team lead for R&D Quality Engineers (m/f/d) you will be leading the local Design/Quality Assurance team in Brno as local team lead 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 the 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 the topic of product quality in a highly regulated industry (medical device, automotive, aviation).
Experience as a team lead or manager is highly preferred.
Knowledge of ISO 13485 is preferred.
Knowledge and application experience in quality and statistical methods.
Experience in system testing, reliability testing and/or software testing and/or hardware testing.
Quality-conscious, trustworthy and reliable.
Structured and systematic way of working.
Good communication skills.
English language skills required (B2-CEFR).
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
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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 if you need a disability accommodation for any part of the employment process.
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