Job Overview
This role is focused on ensuring product quality during early development phases through to commercial.
Key Responsibilities:
* Ensure compliance with policies and procedures, as well as national and international regulations.
* Lead compliance and improvement activities associated with the quality system.
* Apply thorough problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.
* Plan, execute, report, and follow up on quality system audits.
* Provide expertise in the areas of quality assurance, controls, and systems to support and develop the company's QMS.
* Develop and implement control plans, inspection plans, and testing strategies to ensure product compliance with design and regulatory requirements.
* Work closely with suppliers to ensure robust quality agreements are in place.
* Support internal teams in the development of products.
* Collect and analyze data to support statistical rational sample testing requirements.
Requirements
* Bachelor's degree in engineering or a related technical field.
* Minimum of 3 years of experience in Quality engineering within the medical device industry.
* Strong understanding of basic engineering principles.