Summary:
The Quality Engineer ensures that products and materials meet established quality standards throughout the product lifecycle. This role collaborates with engineering, manufacturing, and inspection teams to maintain compliance with regulatory and design control requirements.
Responsibilities:
* Apply and maintain quality standards and protocols for material processing and finished products.
* Collaborate with engineering and manufacturing teams to establish and uphold quality standards.
* Utilize design control principles and quality engineering techniques throughout product development and lifecycle.
* Implement inspection, testing, and evaluation methods to verify material and equipment accuracy.
* Support incoming material inspections to ensure compliance with specifications and regulations.
* Design or specify inspection mechanisms and conduct statistical analyses to identify and address quality issues.
* Ensure corrective actions meet reliability and documentation standards.
* Participate in NCMR and investigation reviews, providing technical QA input and solutions.
* Support effective product control measures and issue resolution.
* Contribute to internal and external audits (MDR, MDSAP, FDA).
* May specialize in design, incoming materials, production control, or reliability as they relate to product quality.
Requirements:
* Level 8 Degree in Engineering, Science, or a related discipline.
* Minimum of 2 years' experience in a highly regulated industry.
* Strong communication, organizational, presentation, and leadership skills.
* Ability to work independently and manage schedules to meet deadlines.
* Demonstrated critical thinking and problem-solving skills with a focus on system performance and business impact