Supplier Quality Engineer Req I D
ESSENTIAL DUTIES AND RESPONSIBILITIES: Other duties may be assigned
Conducts Component Qualifications of new or changed supplier parts
Performs FAI for new product and product changes
Supports suppliers with the validation of their manufacturing processes
Conducts supplier audits and manages audit corrections
Performs root cause analysis and implements effective corrective action for supplier nonconformances
Establishes relationships with suppliers and actively drives continuous improvement
Develops and implements test methods and procedures for inspecting, testing and evaluating product and processes at supplier locations
Develops gauging methodology for products
Performs capability studies and gage R&R
Analyzes improvement opportunities through MRB monitoring
Ensures products and processes comply with regulatory and QSM requirements
EDUCATION, EXPERIENCE, QUALIFICATIONS AND SKILLS: -
Bachelor's degree in Engineering or a technical field is preferred
5 years' experience in a regulated industry that includes FDA and ISO requirements
ASQ certification a plus
Displays developed communication and interpersonal skills: leadership, team orientation, ability to communicate at all levels
Teamwork, communication, positive attitude required to support the manufacturing environment
Ability to read and analyze technical prints and drawings
Problem Solving ability to perform root cause analysis and implement effective corrective actions
Ability to effectively manage and complete multiple projects simultaneously
Ability to conduct Process Failure Mode and Effect Analysis (PFMEA)
Excellent computer skills including but not limited to Microsoft Office Suite
QUALITY AND REGULATORY REQUIREMENTS: -
Knowledge of quality system including the quality manual, quality policy and applicable procedures and work instructions
Establish, implement, and maintain the quality system in accordance to FDA Quality System Regulation, ISO 13485, European Union Medical Device Directives, and Canadian Medical Device Regulations
We will no longer be able to match jobs to the skills in your resume.
1. Resume Copy & paste or upload your resume
Don’t have a resume? Build one now!
2. Cover Letter (Optional)
2. Cover Letter (Optional)
Attached Cover Letter
2. Cover Letter (Optional) Copy & paste or upload your cover letter
Don’t have a cover letter? Build one now!
We will not be able to provide you job matches if you remove your resume.
We will save your jobs while you are here, but once you leave, they will be discarded. To save your jobs for when you return, please sign in.
© 2018, Bold Limited. All rights reserved.