Posted in Architecture 30+ days ago.
This job brought to you by eQuest
Location: Jacksonville, Florida
Provide quality support for New Product Development Teams and Commercialization to ensure new/improved medical device products and processes are in compliance with applicable standards and regulations.
Confer with marketing, sales and customers concerning product design to ensure user needs are met. Lead and participate in risk management activities. Confer with vendors to qualify product and work with supplier quality to qualify vendors. Design and implement inspection methods, equipment, acceptance criteria and sampling plans.
Initiate cost reductions of product inspections. Ensure effective design control and transfer to production. Provide validation, sampling, and statistical analysis support to other functions in the organization. Lead Quality issue resolution by applying root cause methodologies. Perform First Article Inspections to ensure Manufacturing process capability.
* Limit gauge design for dimensional verification.
* Problem solving using root cause methodologies (i.e. DMAIC);
* Applying statistics and software in data analysis (example Minitab)
* Application of failure modes and effects analysis (FMEA);
* Working with suppliers to design inspection systems and resolve quality issues.
* Use of Computer Aided Drafting software package (i.e. Solidedge);
* Quality system regulations and requirements (examples 21 CFR part 820, ISO 13485, ISO 9001, ISO 14971)
* Geometric Dimensioning and Tolerance (GD&T)
Bachelor’s degree in engineering or a related degree and 3 years of experience in manufacturing, development or quality engineering required.
ASQ Quality Engineer certification, lead auditor certification, and/or black belt preferred.
Up to 5%