Job Description
We are seeking a Quality Engineer II to partner with our team as we expand operations.
The Role
This position requires experience and a proven track record in quality and regulatory control of medical devices. The successful candidate will be responsible for ensuring product quality during early development phases through to commercialization.
Responsibilities
* Ensure compliance with policies and procedures and applicable national and international regulations.
* Lead compliance and improvement activities associated with the quality system (e.g., CAPA, audit programs, personnel training).
* Apply thorough, systematic problem-solving methodologies to identify, prioritize, communicate, and resolve quality issues.
* Plan, execute, report, and follow-up on quality system audits.
* Act as an audit escort and/or support in the coordination of backroom activity during inspections as required.
* Provide expertise in the areas of quality assurance, controls, and systems to support and develop the Quality Management System (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, including periodic review of their quality metrics.
* Provide ongoing support to internal teams in the development of products, through first article inspection qualifications, and test method development and approval activities through to commercialization.
* Gather and analyze data to support statistical rational sample testing requirements during early product development and ensure compliance with product specifications, regulations, and internal requirements.
Requirements
* A degree in quality engineering, life science, or a related field.
* 3-5 years of experience at a quality assurance role in the medical device sector, essential, preferably in a FDA/MDR regulated environment.
* Quality certification and lead Auditor certification an advantage.
* In-depth knowledge of quality engineering principles, methodologies, and tools (e.g., FMEA, SPC, Root Cause Analysis, CAPA, investigations etc.).
* Experience in QA activities associated with the design and development of medical devices.
* Results-driven with an ability to handle multiple tasks and operate in a fast-paced environment.
* Excellent interpersonal skills and ability to work with people to achieve results.
* Excellent written and communication skills, fluency in English, attention to detail, and strong technical writing skills.