Job Title: Quality Assurance Professional
Overview:
This is a new opportunity to leverage your expertise in quality assurance and regulatory control to drive product excellence. As a seasoned Quality Assurance professional, you will play a pivotal role in ensuring the quality of medical devices from early development phases through to commercialization.
Responsibilities:
- Ensure compliance with policies, procedures, and applicable regulations.
- Lead initiatives to improve the quality system, including CAPA, audit programs, personnel training, and supplier management.
- Apply systematic problem-solving methodologies to identify, prioritize, communicate, and resolve quality issues.
- Plan, execute, report, and follow up on quality system audits, as well as act as an audit escort during inspections as required.
- Provide expertise in quality assurance, controls, and systems to support and develop the company's quality management system (QMS).
- 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, including periodic review of their quality metrics.
- Offer ongoing support to internal teams in product development, including first article inspection qualifications, test method development, and approval activities through to commercialization.
- Gather and analyze data to support statistical sampling for early product development and ensure compliance with product specifications, regulations, and internal requirements.
Requirements:
- Bachelor's degree in engineering or a related technical field.
- Minimum of three years' experience in quality assurance within the medical device industry, preferably in neurointerventional devices.
- Strong understanding of basic engineering principles.
What We're Looking For:
We are seeking a skilled and experienced Quality Assurance professional who can contribute to our team's success. If you have a proven track record in quality assurance and regulatory control, we encourage you to apply.