Job Description
Summary: Support process transfer of medical devices, lead quality engineering activities, and ensure regulatory compliance.
Job Description:
As a Quality Engineer, you will support the transfer of peripheral interventional devices, new products, and delivery systems from manufacturing or R&D to the manufacturing site. You will represent quality interests and concerns on project teams, ensuring new products and processes meet local, divisional, and corporate requirements for safety and efficacy.
You will be responsible for executing technical tasks of the transfer following an established process, including risk management, test method development and validation, qualification, and launch of the product. You will work closely with various functions onsite and between sites.
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 developing 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, and legislative compliance for all project work.
Requirements:
- Education: Bachelor of Mechanical, Biomedical, Chemical, or other related engineering discipline or Technical/Science qualification (level 8).
- Experience: 2+ years of industrial experience in quality engineering or similar, preferably in a medical device or 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 statistical software is a plus.