We are seeking a dedicated and skilled Quality Engineer with 2 to 5 years of experience to join our dynamic team. This role is instrumental in ensuring the highest quality standards across our production and development programs. The ideal candidate will possess a Bachelor's Degree in Engineering or Science, with a preference for those with a background in Chemical, Mechanical, Biomedical, or Plastics Engineering. A Master's Degree in a related engineering discipline is highly desirable.

The candidate should have a strong foundation in the medical device industry, with at least 5 years of hands-on experience in product quality evaluation and auditing. Possession of ASQ Certification and other advanced quality credentials will be considered advantageous.

Familiarity with Clean Room Principles, cGMP, and expertise in gauging/tooling techniques are beneficial. A working knowledge of ISO 13485, FDA 21 CFR 820, SPC (Minitab), QMS, Quality Assurance Methods, and thermoplastic manufacturing techniques is preferred.

The successful Quality Engineer will be responsible for developing and maintaining quality standards for our products and processes, ensuring that all outputs meet rigorous industry and regulatory standards. This is an excellent opportunity for a proactive and detail-oriented individual to contribute to our commitment to excellence.