Quality Assurance Specialist
This role requires a meticulous professional to oversee product quality and regulatory compliance from development to commercialization.
The ideal candidate will have extensive knowledge of quality engineering principles, methodologies, and tools such as FMEA, SPC, Root Cause Analysis, CAPA, and investigations. They should also have experience in QA activities associated with design and development of medical devices.
* Develop and implement control plans, inspection plans, and testing strategies to ensure product compliance with design and regulatory requirements.
* Collaborate with suppliers to establish robust quality agreements and review their quality metrics regularly.
* Support internal teams through first article inspection qualifications, test method development, and approval activities.
* Gather and analyze data to support statistical rational sample testing requirements and ensure compliance with product specifications, regulations, and internal requirements.
Key Qualifications:
* Bachelor's degree in quality engineering, life science, or a related field.
* 3-5 years of experience in quality assurance roles in the medical device sector, preferably in a FDA/MDR regulated environment.
* Quality certification and lead auditor certification are an advantage.
* Excellent written and communication skills, fluency in English, attention to detail, and strong technical writing skills.
* Proven record of policy and procedure development.