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. This role represents quality interests and concerns on project teams, ensuring that new products and processes meet all local, divisional, and corporate requirements with respect to safety and efficacy.
Responsibilities:
* Leads Quality engineering activities for transfer projects, supporting and participating in NPI teams.
* Develops process risk management documentation with cross-functional support.
* Develops or assists in developing inspection and test methods per product specifications.
* Performs test method validations as required.
* Identifies quality systems engineering improvement opportunities and executes through the change management system.
* Ensures regulatory/statutory/legislative compliance for all project work.
Qualifications:
* 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.
Requirements:
* A valid work permit, stamp 4, or an EU passport.
The estimated salary for this position is €60,000 - €80,000 per annum, based on location and industry standards.