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EU MDR Quality Engineer II

Location: Andover, Massachusetts
Job Category:

EU MDR Quality Engineer II
12+ month contract 

• Assure product design history files meet the regulatory requirements of Medical Device Regulation (MDR 2017.745), internal quality system and other applicable regulations.

• Apply knowledge of ISO 14971 Risk Management; IEC 60601-1 Medical Electrical Equipment and collateral standards, IEC 62366 Usability, and IEC 62304 Software Lifecycle; and other applicable standards to sustaining engineering projects.
• Serve as primary quality representative on one or more EU MDR project teams Ensure risk management documentation is updated in coordination with activities, and interfacing with project team members including engineering, regulatory, marketing, change management, post market surveillance, and production.
• Produce technical reports to support product changes or quality assurance investigations.
• Prepare, evaluate and critique technical documentation including design justifications and rationales based on sound scientific or engineering principles.
• Makes decisions and proposes solutions based on calculated risks identified through data analysis.
• Evaluate procedures and processes within the quality system to identify areas for improvement. Recommend solutions to identified problems.
• Coordinate activities with Quality Engineering Management and report regularly on the progress of activities.
• Participate in meeting departmental goals and objectives; on time project delivery per release project schedule
• Travel requirement: Occasional domestic travel may be required less than 10%

Bachelor’s degree in engineering or equivalent scientific discipline

Preferred experience includes 4+ years at medical device company serving as a Quality Engineer supporting design control teams with a BS degree. Alternative considerations include 4+ years in Quality Assurance in a GMP environment. 2+ year’s experience with a Master’s degree.


Required Qualifications
• Clear and concise written/electronic and verbal communication. Ability to multi-task, prioritize, meets/exceed deadlines and hold themselves accountable.
• Self- starter, with the ability to work independently
• Software programs - Microsoft Word, PowerPoint, Excel, Project.
• Experience with managing documents within electronic PLM system
• Corrective and Preventative action experience including root cause analysis
• Experience with working with cross functional teams
Standards and Regulations
• EU MDR 2017/745
• EU MDD 93/42/EEC
• ISO 13485
• 21 CFR Part 820
• ISO 14971
• 21 CFR Part 820

Preferred Qualifications

• Remoted working environment experience
• Experience with Matrix PLM system
• Experience with SAP
• ASQ certification as a Certified Quality Engineer or Biomedical engineer
• Six-Sigma or equivalent greenbelt certification
• Power-BI-Data Visualization

Standards and Regulations

• IEC 62366
• IEC 62304

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