Job Description
We are seeking a Quality Engineer to join our team. The ideal candidate will have experience in a highly regulated environment and be knowledgeable about Six Sigma techniques.
* This role involves supporting the team responsible for new product introduction, participating in design transfer meetings, and providing input to Design Failure Mode and Effects Analysis (DFMEA).
* The Quality Engineer will ensure Critical-To-Quality (CTQ) cascade from design input to inspection plan.
* They will develop appropriate measurement systems for ongoing product inspection and plan and execute Test Method validation.
The successful candidate will actively participate in engineering studies for process characterization, collect data, and execute various analytical and statistical analyses and interpretation as part of process improvements and day-to-day support.
Key responsibilities include collaborating with projects for process improvement and automation implementation, developing control plans consistent with product classification, and reviewing and releasing production risk management documentation.
Additional duties include producing reports and presentations to internal and external stakeholders.
Required Skills and Qualifications
To be considered for this position, applicants must possess a minimum Bachelor's Degree in a technical field such as Biomedical, Mechanical, or Automation Engineering.
* A minimum of 3 years of analogous working experience in a manufacturing environment is required, preferably in medical devices, pharmaceuticals, or automotive industries.
* Candidates should have experience in a highly regulated environment and knowledge of standards such as ISO 13485 and CFR 21 Part 820.
* Knowledge of Six Sigma techniques and/or inferential statistical techniques is essential.
* Proficiency in MS Office, Agile, and Windchill is desirable.
Benefits
The role offers a unique opportunity to work in a global company that empowers brands that empower the world.
The successful candidate will have the chance to collaborate with a talented team and contribute to process improvements and automation implementations.
This role provides a challenging and dynamic work environment with opportunities for growth and professional development.