Quality Engineer
You will support the process transfer of peripheral interventional devices, new products, and delivery systems from manufacturing or R&D to the Manufacturing site.
Responsibilities:
* Lead quality engineering activities for transfer projects, supporting and participating in NPI teams.
* Develop process risk management documentation with cross-functional support.
* Develop or assist in the development of inspection and test methods per product specifications.
* Perform test method validations as required.
* Identify quality systems engineering improvement opportunities and execute through the change management system.
* Evaluate regulatory/statutory/legislative compliance for all project work.
Requirements:
* Bachelor of Mechanical, Biomedical, Chemical, or other related engineering discipline or Technical/Science qualification (level 8).
* At least 2 years of industrial experience in quality engineering or similar, preferably in medical device or other regulated FDA/QSR and ISO environment.
* Familiarity with regulations including ISO 13485, CFR 11820, ISO 14971, and EU MDR.
* Experience in Risk Management process – PFMEA.
* Knowledge of Gauge R&R and Test Method Validation for Physical & Mechanical Test Methods.
* Excellent attention to detail and adaptability.
* Experience in process validation (IQ, OQ, and PQ) is a plus.
* Excellent interpersonal skills with the ability to work in a team environment and work under own initiative to targets and deadlines.
* Problem-solving techniques with excellent organizational skills.
* Excellent oral and written communication skills.
* Ability to analyze data, interpret results, and write reports. Proficient in statistic software is a plus.