North Austin, TX
Degree with 6+ years of recent QE experience in medical device tech writings and design required, Lean Manufacturing experience, 6S certification is preferred. ISO 13485 experience required. Very strong relocation package offered.
Job Description:
This position primarily supports New Product Development and serves as the QA representative on new product initiatives
Essential Duties and 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
Qualifications:
- Bachelor’s in Biomedical or Mechanical Engineering and 5+ 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.
- The individual should have knowledge of Microsoft Office Suite of software or equivalent.
- Preferred knowledge of the following software packages: SolidWorks, SolidWorks ePDM, Oracle R12, Agile PLM.
- Prefer CQE, Lean, or 6 Sigma Certification