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
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
SOP’s. 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 IQ’s / OQ’s
· 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.
· 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
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
Nachman BioMedical - Leaders in Biomedical Search and Placement - Our 22nd year