Responsibilities:
 
Drive and implement all existing  product design 
changes.
Optimize designs of existing surgical implants 
and tools.
Interact with current/new suppliers to monitor 
schedules and print specifications.
Maintain and enhance TriMed quality system
Interface with development teams during new 
product development to define inspection 
criteria for parts, sub-assemblies and final 
assemblies 
Understand supplier IQ, PQ, OQ processes and how 
they will affect TriMed 
Design and oversee fabrication of inspection 
fixtures, including validation and maintenance 
activities 
Develop QC processes and procedures for 
incoming, in-process, and finished device 
inspections  
Participate in root cause analyses on product 
failures and returned goods, and work with 
suppliers and R&D to implement corrective action 
Provide training on inspection procedures to QC 
inspectors 
Oversee outsourced calibration of tools and 
equipment 
Conduct and maintain regular supplier audits.
 
Requirements: 
 
Four-year degree in relevant Engineering field, 
or equivalent 
Experience in an mechanical manufacturing 
environment 
Experience as a Quality Engineer 
Experience on a medical device manufacturing 
team 
Knowledge of FDA QSRs, ISO-9001, ISO-13485 
Ability to read, write, speak and understand 
English 
Working knowledge of inspection metrology tools 
and equipment 
Basic computer skills with a focus on CAD (ProE 
experience preferred)