Job Title: Senior Medical Device Quality Engineer
Date Posted: 10-26-2007
Job Location: Massachusetts-Boston
Job Type: Full Time
Education Level: Bachelors Degree
Work Experience: 5+ to 7 Years
Job Shift: First Shift
Yearly Salary:DOE (Depend on Experience)
Company Name: Nachman BioMedical
Contact Information: Phillip   Nachman (phil@nachmanbiomedical.com)
Job Description:
Expanding, well funded young medical device company with groundbreaking technologies involving
sophisticated plastic disposables, and advanced instrumentation.  Company growth has created
an outstanding  career opportunity for a well qualified, motivated Quality Engineer.  This a
visible position in a highly valued team, in an enterprise making important advances in
healthcare. 

 

Work as a key member of the Quality team to continue the development of the ISO 13485 Quality
Management System and be the driver for various aspects of that system. Help insure compliance
with QSR regulations as well as company 

SOPs. Maintain a team work / team building approach with all tasks, and nurture professional
relationships with other departments and outside agencies. 

Assist in ensuring accurate and timely processing of all Quality Records and documentation.  

 

Essential Duties and Responsibilities: 

 

 Contribute to the documentation of the ISO-13485 Quality Management  System
      Administer the Calibration System 

      Contribute to Process and Design / FMEA Reviews 

      Develop and drive the inspection requirements to move product 

      Contribute to Material Review Board 

      Write and complete Process and Product Validations 

      Write Equipment Installation and Operation Qualifications  IQs / OQs

      Participation in supplier and internal Audits

      Help facilitate continuous improvement and learning across all functional areas through
training and communication of quality initiatives

      Review/ Approve nonconforming materials and associated documentation.   

 

Qualifications: 

      A minimum of 5 years medical device quality engineering    experience, with disposables
and/or electronics. Thorough working knowledge of FDA quality  regulations

       BS in engineering.

Strong engineering skills with a working knowledge of process validations and verification
activities. 
Problem solving techniques including root cause analysis and cause and effect analysis. 
Solid working knowledge of Quality System Regulations 
Excellent written and verbal skills. 
Ability to define problems, collect data, establish facts and draw conclusions 
Ability to effectively present information in one on one and small group situations 
Excellent interpersonal, analytical and organizational skills
 

You can learn about additional medical device and biopharmaceutical career opportunities at
www.nachmanbiomedical.com

 

Nachman BioMedical -   Leaders in Biomedical Search and Placement -   Our 22nd year
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