Job Description
We are seeking a dynamic and experienced Quality Engineer II to join our team at Wallace Myers International.
Key Responsibilities:
* Ensure product quality during early development phases through to commercial, including batch release, internal audits, and supplier management.
* Lead compliance and improvement activities associated with the quality system, applying thorough, systematic problem-solving methodologies to identify, prioritize, communicate, and resolve quality issues.
* Plan, execute, report, and follow-up on quality system audits, providing expertise in quality assurance, controls, and systems to support and develop the 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.
Requirements:
* Degree in quality engineering, life science, or related field.
* 3-5 years experience in a quality assurance role in the medical device sector, 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, such as FMEA, SPC, Root Cause Analysis, CAPA, and investigations.
* Experience in QA activities associated with the design and development of medical devices.
* Results-driven with excellent interpersonal skills and ability to work with people to achieve results.
Educational Requirements:
A degree in quality engineering, life science, or related field is essential for this role.
Desirable Skills:
* Knowledge of FDA's 21 CFR Part 820 (Quality System Regulation) and ISO.
* Experience in test development and reporting, batch release, first article inspections (FAI), data collection for sample testing, and supplier qualification and evaluation processes.
* Excellent written and communication skills, fluency in English, attention to detail, and strong technical writing skills.
* Good business acumen and an enthusiastic self-starter.