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Quality Engineer R&D - Medical Devices

Company:
Novanta
Location:
Brno, South Moravian, Czech Republic
Posted:
May 16, 2024
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Description:

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.

We are looking for a new Quality Engineer to join our R&D team in Brno! The Quality Engineer will be part of a team developing medical devices for minimally invasive surgeries, e.g. laparoscopy, etc.

Sign-on bonus 100 000 CZK for new employees.

Primary Responsibilities:

Support the creation of an overall superior quality plan including a document plan and overall VnV plan.

Review of design verification and validation test specification for medical devices (equipment and consumables).

Review of design control documents according to GLP, GDP, CFR820.

Member of the product and design FMEA team.

As a member of the risk management team according to ISO 14971:

Contribute to the content of the risk management throughout the product development.

Review of the systematics and completeness of the risk analysis.

Evaluation of risk-reducing measures regarding the impact on the severity of damage and probability of occurrence.

Creation and review of the evidence for implementation and effectiveness of the measures.

In cooperation with Quality Assurance and Production:

Involvement in the preparation of test specifications and test requirements for the series testing of medical devices.

Other tasks:

Active participation in measures for synchronization and improvement of processes.

Failure analysis for field returns and during development.

Strict compliance with quality, occupational safety, and environmental regulations and implementation of instructions by quality/environmental officers and the specialist for occupational safety.

Required Experience, Education, Skills and Competencies:

Completed technical and/or physical studies.

At least 2 years of professional experience.

Experience with product quality in a highly regulated industry (medical device/automotive/aviation etc.)

Experience in theory and application of quality methods and techniques.

English language skills (B2) are required.

Quality-conscious, trustworthy, and reliable.

Team player.

Good communication skills.

Structured and systematic way of working.

Travel Requirements:

Willingness to travel to all locations and business contacts (10%) - Berlin mainly.

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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.

R006928

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