NPI Quality Engineer

Enovis•Houston, TX

1d•$86,520 - $104,174•Onsite

About The Position

The NPI Quality Engineer is a key member of Enovis’s Foot & Ankle Quality NPI team and supports New Product Development, Sustaining Product Development, and Complaint Investigations. The position serves as the Quality Assurance representative on product development initiatives and applies engineering and problem-solving principles to design, implement, and maintain quality assurance procedures and work instructions. The role helps ensure safety, quality, and compliance with company standards and government regulations. The position is based in Houston, Texas, and reports to the Sr. NPI Quality Manager. Travel requirements are up to 20%.

Requirements

Bachelor’s degree in Biomedical or Mechanical Engineering and 5+ years of experience, or an equivalent combination of education and years of experience.
Background in a medical device, aeronautics, automotive, or other highly regulated industry.
Knowledge of technical writing quality and best practices.
Basic knowledge of manufacturing processes, with a focus on metrology, precision machining, grinding, product cleaning, and sterilization.
Knowledge of Microsoft Office Suite or equivalent.
Must already have full-time work authorization in the United States, now and in the future, without employment visa sponsorship.

Nice To Haves

Knowledge of ISO 13485 quality standards.
Advanced knowledge of ISO 14971 and risk management principles.
Experience with Class II/III medical devices.
Knowledge of Solidworks, Solidworks ePDM, MiniTab, Netsuite, Agile PLM, CMM, and/or automated inspection system programming.
CQE, Lean, or Six Sigma certification.
Detail-oriented and analytical.

Responsibilities

Participate in design and manufacturing reviews.
Generate DFMEAs/UFMEAs and participate in risk analysis discussions.
Develop inspection strategies and methods to support new product development and launch.
Review and approve design and development documentation.
Serve as a subject matter expert for design quality during ISO and FDA audits.
Author procedures and work instructions that define and govern the quality system.
Conduct internal audits of the quality system and other business functions.
Evaluate nonconforming material and determine disposition based on cross-functional engineering review.
Assure compliance with internal and external specifications and standards, including GMP, ISO, FDA, and MDD.
Review trends in device failures associated with customer complaints and nonconforming material.
Lead and own corrective and preventive actions and complaint investigations.
Work on complex special projects as assigned.