Quality Engineer Jobs

Degree in Mechanical, Materials, or Biomedical Engineering with minimum 4 years of experience

Experience in 483 / Audit remediation for supplier-related problems.

Working independently with the internal and external stakeholders for execution.

Provides Quality Engineering support for commercial Medical products.

Applies knowledge of design control principles, statistics, process & and systems validation, and quality engineering techniques to positively influence projects and manufacturing.

Ensures changes to products are developed and manufactured in accordance with applicable industry standards, regulatory requirements, and customer requirements.

Apply various engineering principles including metallurgy, heat transfer, strength of materials, statics, sterilization, and biocompatibility.

Utilizes quality tools to include Risk analysis FMEA, statistical techniques including six-sigma and DOE (design of experiments), root cause analysis, reading and correcting drawings.

Navigate complex government regulations to include FDA & QSR requirements and guidance under 21 CFR820, ISO13485, and ISO14971.

Present technical data to groups within and outside the organization.

Develops, modifies, applies, and maintains quality standards and protocols for processing materials into partially finished or finished materials products.

Collaborates with engineering and manufacturing functions to ensure quality standards are in place.

Devices and implements methods and procedures for inspecting, testing, and evaluating the precision and accuracy of products and production equipment.