Responsible for developing and maintaining many of the quality assurance functions such as process validation, procedure development/training, SPC/SQC, resolving internal/external nonconformances and resolving customer concerns. This position will require an individual with the ability to work on multiple projects with changing priorities.
- Works with engineering on the planning, development and launch of new projects.
- Manages the completion of first article inspection reports, process validation protocols, PFMEA, PPAP, measurement system analysis, master validation plans, device master records
- Maintain customer relations: resolving customer complaints, understanding specifications and the project scope and quality development
- Responsible for the implementation of statistical process control (SPC) and statistical quality control (SQC) including the use of design of experiments, ANOVA, T-Tests, control charts, process capability studies
- Develop, implement and perform scientific sampling techniques to determine product/process acceptability on incoming, in-process and finished product
Desired Skills & Experience
- Bachelor’s Degree (preferably in a field that offers as opportunity to gain a well rounded background) or equivalent trade school diploma preferred
- Strong statistics background with demonstrated application of quality tools: Six Sigma, Lean manufacturing, SPC/SQC, design of experiments
- Preferred five years experience as quality engineer in injection molding
- Experience and comfort working within a Quality Management System: ISO 9001 and/or 13485, TS 16949
- Working knowledge of Microsoft Office, Minitab (or other statistical software), Solidworks (or other CAD software)
- Demonstrated interpersonal skills with the ability to work and lead within a team environment
Indeed - 6 months ago