NPI Quality Engineer – Medical Devices

Encore Medical LP; Houston (TX); In loco; USD 87.000 - 104.000; Tempo pieno

Vantaggi offerti da questo lavoro

Travel up to 20%

Descrizione del lavoro

Enovis Corporation, a medical technology innovator, is seeking a Quality Engineer for the Foot & Ankle Quality NPI team to drive design quality and regulatory compliance across ISO and FDA audits.

The role focuses on DFMEAs/UFMEAs, risk analysis, inspection strategy, and collaboration with cross-functional teams to ensure compliant product launches and superior patient outcomes. Travel up to 20% may be required.

Competenze

• Bachelor’s degree in Biomedical or Mechanical Engineering and 5+ years of experience (or equivalent combination of education and years of experience).
• Background in Medical Device, Aeronautics, Automotive or other highly regulated industry; ISO13485 knowledge preferred.
• Knowledge of technical writing quality and best practices.
• Basic knowledge of manufacturing processes: metrology, precision machining, grinding, product cleaning, sterilization.
• Microsoft Office Suite proficiency.

Mansioni

• Participating in design and manufacturing reviews.
• Generating DFMEAs/UFMEAs and participating in risk analysis discussions.
• Develop inspection strategy and methods to support 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 business functions.
• Evaluating nonconforming material and dispositioning based on cross-functional engineering review.
• Ensuring compliance to internal and external specifications and standards (ISO, FDA).
• Reviewing trends in device failures and customer complaints.
• Leading corrective and preventive actions and complaint investigations.
• Working on complex special projects.

Conoscenze

5+ years experience

Regulatory quality

Microsoft Office

Formazione

Bachelor's degree in Biomedical or Mechanical Engineering

Strumenti

Solidworks

Solidworks ePDM

MiniTab

Netsuite

Agile PLM

CMM

Descrizione del lavoro

Enovis Corporation, a medical technology innovator, is seeking a Quality Engineer for the Foot & Ankle Quality NPI team to drive design quality and regulatory compliance across ISO and FDA audits.

The role focuses on DFMEAs/UFMEAs, risk analysis, inspection strategy, and collaboration with cross-functional teams to ensure compliant product launches and superior patient outcomes. Travel up to 20% may be required.