R&D Quality Engineering Manager

Reposted 8 Days Ago
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Brno, Brno-město, Jihomoravský kraj
In-Office
Mid level
Appliances • Industrial • Manufacturing
The Role
Lead the local Design Assurance team, create quality plans, manage product testing, and ensure compliance with regulations in a medical device context.
Summary Generated by Built In

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.

As our new Manager 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 quality within R&D engineering.
  • Experience with the topic of product quality in a highly regulated industry (e.g. medical devices, automotive, aviation).
  • Experience as a team lead or manager.
  • Knowledge of ISO 13485 is preferred.
  • 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).
  • 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.

Top Skills

Cfr820
Design Control
Fmea
Gdp
Glp
Iso 13485
Iso 14971
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The Company
Manchester
2,075 Employees

What We Do

Novanta delivers innovations that matter for its medical and advanced industrial OEM customers. If you have a passion for solving complex technical problems that lead to breakthrough performance and that enhance people's lives, come join our growing team.

Here is a sample of the many exciting applications we serve:
• Innovations that ensure the safety of patients and efficient workflows in hospitals using our novel RFID technology
• Innovations in additive manufacturing, also known as 3-D metal printing, using our lightning fast lasers and laser beam steering sub-systems
• Innovations in minimally invasive surgery using our highly reliable insufflators, pumps and visualization systems
• Innovations in robotics and automation using our precision motors, encoders and drives for superior accuracy
• Innovations in smartphone production using our fast, accurate lasers and laser beam steering equipment along with our precision motion systems

The driving force behind our growth is the team of talented professionals who share our commitment to our values, and our passion for innovation and for our customers’ success.

Novanta has deep expertise in precision medicine and manufacturing, medical solutions, and robotics and automation:

Precision Medicine and Manufacturing:
• Continuous wave, ultrafast and CO2 lasers, along with laser beam steering components and sub-systems
Brands: ARGES, Cambridge Technology, Laser Quantum, Synrad

Medical Solutions:
Minimally Invasive Surgery:
• Insufflators, pumps and disposable tube sets; medical visualization systems, video processing and wireless imaging
Brands: NDS, Med X Change, Reach Technology, WOM
Detection & Analysis:
• RFID readers, machine vision solutions, barcode scanning, light and color measurement
Brands: JADAK

Robotics and Automation:
• Motors, encoders, servo drives, air bearing systems and integrated mechatronic solutions
Brands: ATI, Celera Motion (inc. Applimotion, Ingenia, MicroE, Zettlex, Westwind)

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