NPI Quality Engineer – Medical Devices

Enovis; Houston (TX); On-site; USD 87,000 - 104,000; Full time

Benefits offered by this job

Medical Insurance

Dental Insurance

Vision Insurance

401(k) Plan

Vacation, Sick Leave, and Holidays

Job summary

Enovis in Houston, TX is seeking an experienced NPI Quality Engineer to support New Product Development, Sustaining Product Development and Complaint Investigations within the Foot & Ankle unit. You will apply your knowledge of engineering and quality systems to design, implement and maintain QA procedures and work instructions, and to ensure compliance with GMP, ISO and FDA requirements.

Travel up to 20% may be required; the position requires a Biomedical or Mechanical Engineering degree and 5+

Qualifications

• Bachelor's degree in Biomedical or Mechanical Engineering and 5+ years of experience.
• Background in Medical Device, Aeronautics, Automotive or other highly regulated industry; ISO13485 knowledge preferred.
• Knowledge of manufacturing processes: metrology, precision machining, grinding, product cleaning, and sterilization.
• Proficient with Microsoft Office Suite.

Responsibilities

• Participating in design and manufacturing reviews.
• Generating DFMEAs/UFMEAs and participating in risk analysis discussions.
• Develop inspection strategy and methods to support the development and launch of new products.
• Reviewing and approving design and development documentation.
• Serve as SME for design quality in ISO and FDA audits.
• Authoring procedures and work instructions that define and govern the quality system.
• Conduct internal audits of the quality system and other functions.
• Evaluating nonconforming material and dispositioning based on cross-functional engineering review.
• Ensuring compliance to GMP, ISO, FDA, and related standards.
• Reviewing trends in device failures and customer complaints.
• Leading corrective and preventive actions and complaint investigations.

Skills

ISO 13485 knowledge

GxP awareness

Microsoft Office

Education

Biomedical or Mechanical Engineering degree

Tools

Solidworks

Solidworks ePDM

MiniTab

Netsuite

Agile PLM

CMM programming

Automated inspection systems

Job description

Enovis in Houston, TX is seeking an experienced NPI Quality Engineer to support New Product Development, Sustaining Product Development and Complaint Investigations within the Foot & Ankle unit. You will apply your knowledge of engineering and quality systems to design, implement and maintain QA procedures and work instructions, and to ensure compliance with GMP, ISO and FDA requirements.

Travel up to 20% may be required; the position requires a Biomedical or Mechanical Engineering degree and 5+