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As our new R&D Quality Engineer (m/f/d) you are part of the MDR project team to transform existing medical device files in accordance with MDR 2017/745. This involves the creation, update and review of process-compliant documentation for these existing medical devices for all documents created during Design Control and related processes.

Your tasks:

• Creation, update and review of process-compliant documentation for existing medical devices for all documents created during Design Control and related processes.

In addition the role as regular Design Assurance Engineer involves:

• 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 also participate on 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 studies and at least 3 years of professional experience as quality engineer in R&D area
• Experience with the topic of product quality in a highly regulated industry (medical device, automotive, aviation)
• Knowledge of MDR 2017/745 and ISO 13485 (ISO optional)
• Knowledge and application experience in quality and statistical methods
• Overview of processes such as system testing, reliability testing and/or software testing and/or hardware testing is preferred
• Quality-conscious, trustworthy and reliable
• Structured and systematic way of working
• Good communication skills
• English language skills required (B2-CEFR)
• Willingness to travel to Berlin (cca 15%)

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

Your tasks:

• Creation, update and review of process-compliant documentation for existing medical devices for all documents created during Design Control and related processes

In addition the role as regular Design Assurance Engineer involves:

• 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 also participate on 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 safet