Design Quality Engineer

About the role

Utilizing a comprehensive knowledge of engineering and problem-solving principles, this position is responsible for a variety of complex activities regarding the design, implementation, and maintenance of quality assurance procedures and work instructions to ensure external safety, quality, and compliance with complex Company standards and government regulations. This position primarily supports New Product Development and Sustaining Product Development and serves as the QA representative on various PD initiatives.

Responsibilities

• Participating in design and manufacturing reviews
• Generating DFMEAs/UFMEAs and participating in risk analysis discussions
• Reviewing and approving design and development documentation
• Serving as subject matter expert for design quality in ISO and FDA audits
• Authoring procedures and work instructions that define and govern the quality system
• Conducting internal audits of the quality system and other business functions
• Evaluating nonconforming material and dispositioning based on cross-functional engineering review
• Assuring compliance to internal and external specifications and standards (i.e. GMP, ISO, FDA, MDD)
• Reviewing trends in device failures associated with customer complaints and nonconforming material
• Leading and owning corrective and preventive actions
• Working on complex special projects as assigned

Requirements

• Bachelor’s in Biomedical or Mechanical Engineering and 3+ years of experience
• Background in Medical Device, Aeronautics, Automotive or other highly regulated industry required; preferred knowledge of ISO13485 quality standards
• Knowledge of technical writing quality and best practices
• Required basic knowledge of manufacturing processes: key focus into metrology, precision machining, grinding, product cleaning, and sterilization
• Individual should have knowledge of Microsoft Office Suite of software or equivalent

Qualifications

• Preferred knowledge of the following software packages: Solidworks, Solidworks ePDM, Oracle R12, Agile PLM
• CQE, Lean, or 6 Sigma Certification

Desired Characteristics

• Advanced knowledge of ISO 14971 and risk management principles
• Detail oriented and analytical

Physical Requirements

• Ability to sit/stand for long periods of time

Work Environment

• General office setting