What are the responsibilities and job description for the Senior/Principal Quality Engineer (Failure Analysis) position at Jobot?
Want to learn more about this role and Jobot? Click our Jobot logo and follow our LinkedIn page!
Job details
Long standing Medical Device company seeks Sr Quality Engineer!
This Jobot Job is hosted by Aaron Erickson
Are you a fit? Easy Apply now by clicking the "Easy Apply" button and sending us your resume.
Salary $90,000 - $160,000 per year
A Bit About Us
Looking to lead in a state of the art medical device technology? Established Medical Device firm that leads in the forefront of their field seeks to add a Sr Quality Control Engineer.
Why join us?
Excellent Pay!
Great Benefits!
Working on state of the art medical device technology!
Career Growth Opportunities!
Job Details
We are seeking a dedicated professional to manage medical device complaint investigations, ensuring compliance with applicable regulations and quality standards. This role focuses on conducting timely, accurate failure investigations, root cause analyses, risk assessments, and Corrective and Preventive Actions (CAPA). The position involves collaborating with cross-functional teams, performing trend analysis on complaint data, and contributing to continuous improvement efforts.
Key Responsibilities
Complaint Investigations and Reporting
Conduct comprehensive investigations of medical device complaints, ensuring adherence to regulations and quality system requirements.
Analyze complaint data for trends and recommend risk management updates.
Document findings accurately and in a timely manner in the complaint management system.
Root Cause Analysis and Failure Testing
Perform in-depth root cause analyses through data acquisition, physical device deconstruction, and laboratory testing.
Design and execute experiments to validate theories and refine failure modes.
Use laboratory equipment (e.g., probes, X-ray systems, digital microscopes, electrical test software) to perform tests and failure analyses.
Collaboration and Communication
Work closely with engineers, suppliers, clinical specialists, and operations teams to facilitate effective problem-solving.
Provide updates and findings during cross-functional team meetings.
Communicate clearly in both verbal and written formats.
Quality and Risk Management
Lead cross-functional teams to analyze complaint trends and propose updates to risk management documentation.
Use quality tools and statistical methods (e.g., root cause analysis, pareto charts) to drive data-informed decisions.
Ensure CAPA activities address product field failures effectively.
Additional Responsibilities
Stay updated on regulatory requirements (e.g., GMPs, ISO).
Support Quality Management with complaint status updates and adhere to company instructions.
Perform other assigned tasks and projects as needed.
Qualifications
Education
Bachelor’s degree in Mechanical Engineering, Electrical Engineering, Computer Science, or a related field is required.
Advanced degree or certifications (e.g., ASQ, CQE, Six Sigma) are preferred.
Experience
Minimum of 5 years of experience in the medical device industry.
At least 2 years in a failure analysis role.
Proficiency in electrical engineering principles.
Experience with complaint handling tools (e.g., Sparta TrackWise Digital) is a plus.
Skills and Competencies
Strong knowledge of statistical methods (e.g., trend analysis, DOE).
Proficiency in analytical tools, software, and testing equipment.
Ability to work independently and collaboratively in a team environment.
Exceptional organizational and problem-solving skills.
Interested in hearing more? Easy Apply now by clicking the "Easy Apply" button.
Want to learn more about this role and Jobot?
Click our Jobot logo and follow our LinkedIn page!
Job details
Long standing Medical Device company seeks Sr Quality Engineer!
This Jobot Job is hosted by Aaron Erickson
Are you a fit? Easy Apply now by clicking the "Easy Apply" button and sending us your resume.
Salary $90,000 - $160,000 per year
A Bit About Us
Looking to lead in a state of the art medical device technology? Established Medical Device firm that leads in the forefront of their field seeks to add a Sr Quality Control Engineer.
Why join us?
Excellent Pay!
Great Benefits!
Working on state of the art medical device technology!
Career Growth Opportunities!
Job Details
We are seeking a dedicated professional to manage medical device complaint investigations, ensuring compliance with applicable regulations and quality standards. This role focuses on conducting timely, accurate failure investigations, root cause analyses, risk assessments, and Corrective and Preventive Actions (CAPA). The position involves collaborating with cross-functional teams, performing trend analysis on complaint data, and contributing to continuous improvement efforts.
Key Responsibilities
Complaint Investigations and Reporting
Conduct comprehensive investigations of medical device complaints, ensuring adherence to regulations and quality system requirements.
Analyze complaint data for trends and recommend risk management updates.
Document findings accurately and in a timely manner in the complaint management system.
Root Cause Analysis and Failure Testing
Perform in-depth root cause analyses through data acquisition, physical device deconstruction, and laboratory testing.
Design and execute experiments to validate theories and refine failure modes.
Use laboratory equipment (e.g., probes, X-ray systems, digital microscopes, electrical test software) to perform tests and failure analyses.
Collaboration and Communication
Work closely with engineers, suppliers, clinical specialists, and operations teams to facilitate effective problem-solving.
Provide updates and findings during cross-functional team meetings.
Communicate clearly in both verbal and written formats.
Quality and Risk Management
Lead cross-functional teams to analyze complaint trends and propose updates to risk management documentation.
Use quality tools and statistical methods (e.g., root cause analysis, pareto charts) to drive data-informed decisions.
Ensure CAPA activities address product field failures effectively.
Additional Responsibilities
Stay updated on regulatory requirements (e.g., GMPs, ISO).
Support Quality Management with complaint status updates and adhere to company instructions.
Perform other assigned tasks and projects as needed.
Qualifications
Education
Bachelor’s degree in Mechanical Engineering, Electrical Engineering, Computer Science, or a related field is required.
Advanced degree or certifications (e.g., ASQ, CQE, Six Sigma) are preferred.
Experience
Minimum of 5 years of experience in the medical device industry.
At least 2 years in a failure analysis role.
Proficiency in electrical engineering principles.
Experience with complaint handling tools (e.g., Sparta TrackWise Digital) is a plus.
Skills and Competencies
Strong knowledge of statistical methods (e.g., trend analysis, DOE).
Proficiency in analytical tools, software, and testing equipment.
Ability to work independently and collaboratively in a team environment.
Exceptional organizational and problem-solving skills.
Interested in hearing more? Easy Apply now by clicking the "Easy Apply" button.
Want to learn more about this role and Jobot?
Click our Jobot logo and follow our LinkedIn page!
Salary : $90,000 - $160,000
