Quality engineer

Quality Engineer

You will support the transfer of process for peripheral interventional devices, new products and delivery systems from manufacturing or R&D to the Manufacturing site.


Key Responsibilities:

* Represent quality interests and concerns on project teams, ensuring new products and processes meet all requirements with respect to safety and efficacy.
* Execute technical tasks of the transfer following an established transfer process, including risk management, test method development and validation, qualification, and launch of the product.
* Work closely with different functions onsite and between sites.


Additional 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 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.
* Ensure 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).
* 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 organisational skills.
* Excellent oral and written communication skills.
* Ability to analyze data, interpret results, and write reports. Proficient in statistic software is a plus.


Eligibility: