Biomerics FMI, LLC
Biomerics is a leading full-service medical device contract manufacturer providing material and process technology for the interventional cardiology, interventional radiology, vascular access, and advanced surgical device markets.
Quality Engineer
Biomerics FMI, LLC
Biomerics FMI, LLC
1605 Enterprise Drive
75751 Athens , TX
Job Description: 

Directs the efforts of other Quality personnel to perform activities necessary to support quality aspects of the manufacture and post production activities of components and finished product.

Responsibilities Include: 
  • Lead quality assurance in support of manufacturing actives in accordance with the requirements of USFDA CFR 820, ISO 13485, and MHLW Ministerial Ordinance 169.
  • Manage validation activities as established by USFDA CRF 820, ISO 13485, MHLW Ministerial Ordinance 169 and other regulatory bodies as required.
  • Support engineering efforts by developing, implementing, and maintaining quality requirements and standards throughout the design transfer and manufacturing of products.
  • Develop, execute and analyze quality data.
  • Interface with supplier and customer quality representatives concerning quality related issues.
  • Lead or assist in the risk analysis process.
  • Assist in the resolution of non-conforming product, customer complaints, and corrective action.
  • Develop new inspection test methods and perform method validation as necessary.
  • Facilitate and promote use of appropriate problem-solving techniques for effective root cause analysis and successful corrective action.
  • Other duties as assigned.
  • Bachelor's Degree in engineering or related science.
  • Minimum of 3 years' experience in quality engineering in a manufacturing environment for a company in a regulated industry (IVD, pharmaceuticals, medical device, biologics, etc.)
Special Skills/Abilities/Knowledge: 

Required Skills:

  • Strong knowledge of FDA, GMP & ISO requirements. 
  • Good written and oral communication skills-displays developed interpersonal skills: leadership, team orientation, ability to communicate at all levels. 
  • Flexibility and Adaptability-make effective decisions and maintain effectiveness under changing circumstances and priorities. 
  • Ability to read and analyze technical prints and drawings. 
  • Strong Problem-solving skills able to perform root cause analysis and implement effective corrective actions. 
  • Computer Skills-excellent computer skills including but not limited to standard statistical analysis software and Microsoft Office Suite. 
  • Must be self-motivated and able to build consensus.
  • Decision making skills-must be a critical thinker, using logic and reasoning to identify the strengths and weaknesses of alternative solutions, conclusions or approaches to new opportunities.
Work Environment: 

The person in this position needs to be able to stay in a stationary position 50% of the time throughout the workday. Other times, the person is required to be on the production floor assessing procedures, processes and reviewing alternate solutions to production floor challenges.
This position is required to detect/perceive/inspect with or without visual aids such as contacts or eye glasses. The person in this position is required to operate a computer, office equipment, and production floor machinery throughout the day. Reasonable accommodation available.