Experience Requirements
3-5 years of experience in the following skills:
Quality Engineering
Problem Solving and Quality Improvement
SPC and Statistical Evaluation Techniques
Supplier Quality Improvement
Internal Auditing
Qualification Requirements
4 year degree
ASQ certified Quality Engineer
Preferred Qualifications
CQE preferred
Six Sigma Green Belt preferred. Experience with medical device manufacturing and FDA beneficial.
Responsibilities
Assist in operational, managerial and engineering activities to ensure that the quality of the product and service are achieved, maintained and improved.
1. Provide statistical process control (SPC), process capability studies and statistical analysis support to manufacturing and engineering departments
2. Conduct problem solving and root cause analysis to support failure investigations initiated to resolve quality problems identified from customer complaints, internal nonconformances and manufacturing process yields
3. Review new and revised inspection criteria for proper sampling plan, understanding of inspection technique, availability of inspection tools and accuracy of the acceptance criteria
4. Conduct design of experiments (DOE) to identify critical variables in a process and establish design limitations
5. Create process FMEAs to support validation and analysis and design transfer projects
7. Identify and create trend analysis for key quality performance indicators and NC/CAPA effectiveness monitoring
8. Identify and implement opportunities to improve quality system and manufacturing processes
9. Provide other departmental support as requested by immediate supervisor
10. Adhere to and ensure the compliance of Teleflex Medical’s Code of Conduct, all Company policies, rules, procedures and housekeeping standards