Job Title: Quality Assurance Specialist
Job Description
This position provides Quality Engineering support to various teams within the organization. The ideal candidate will have a strong understanding of ISO 13485, ISO 14971, and the EU Medical Device Regulation 2017/745.
Key Responsibilities:
* Reviewing validation documentation and change requests
* Conducting design and process FMEAs
* Providing quality engineering support to research and development and sustaining engineering departments
* Liaising with production and quality control teams
* Contributing to the Corrective and Preventive Action program (CAPAs) and non-conforming product process
* Investigating complaints, performing risk assessments, and providing quality engineering support to the quality system
* Initiating, managing, and executing projects for continuous improvement
Required Skills and Qualifications
The successful candidate will possess:
* A strong understanding of ISO 13485, ISO 14971, and the EU Medical Device Regulation 2017/745
* Excellent analytical and problem-solving skills
* Effective communication and collaboration skills
* Able to work in a fast-paced environment
Benefits
This role offers:
* An opportunity to make a significant impact on the organization's quality and compliance
* A collaborative and dynamic work environment
* Professional growth and development opportunities
Others
Please note that this is a general job description and may be subject to change.
The organization is an equal opportunities employer and welcomes applications from diverse candidates.