RA/QA Engineer

Enovis•Austin, TX

5d•Onsite

About The Position

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.

Requirements

Bachelor’s in Biomedical or Mechanical Engineering and 2+ years of experience.
Background in Medical Device, Aeronautics, Automotive or other highly regulated industry required
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.
Advanced proficiency in Microsoft applications, particularly Excel and Word.
Working knowledge of US and International quality system regulations.
Strong interpersonal communication and teamwork skills.
Excellent organizational, prioritization, and communication-skills (written and verbal) required.
Fluent in English (oral and written)

Nice To Haves

preferred knowledge of ISO13485 quality standards.
Spanish, German, and/or French-speaking is a plus.
Preferred knowledge of the following software packages: Solidworks, Solidworks ePDM, Oracle R12, Agile PLM.
CQE, Lean, or 6 Sigma Certification.
Advanced knowledge of ISO 14971 and risk management principles
Detail oriented and analytical
Life sciences quality/regulatory industry experience desired (medical devices, pharmaceutical or biotech)

Responsibilities

Participating in design and manufacturing reviews
Generating DFMEAs/UFMEAs and participating in risk analysis discussions
Reviewing and approving design and development documentation
Serve as subject matter expert 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
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