Bachelor's in Biomedical or Mechanical Engineering with 3+ years of experience, including 1 year in a design-focused environment.
Experience in highly regulated industries like Medical Device, Aeronautics, or Automotive; knowledge of ISO13485 preferred.
Familiarity with technical writing quality and best practices.
Basic understanding of manufacturing processes, particularly in metrology and sterilization.
Proficient in Microsoft Office Suite or equivalent software.
Responsibilities
Participate in design and manufacturing reviews to ensure quality standards are met.
Generate DFMEAs/UFMEAs and engage in risk analysis discussions.
Review and approve design and development documentation for compliance.
Act as a subject matter expert during ISO and FDA audits.
Author procedures and work instructions to govern the quality system.
Conduct internal audits of the quality system and related business functions.
Evaluate nonconforming materials and determine disposition through cross-functional reviews.
Benefits
Opportunity to work on New Product Development and Sustaining Product Development initiatives.
Engagement in complex special projects that enhance professional growth.
Exposure to ISO and FDA audit processes, enhancing industry knowledge.
Work in a collaborative environment with cross-functional teams.
Potential for professional development through certifications like CQE, Lean, or Six Sigma.
Full Job Description
Job Title:
Quality Assurance Engineer - Design Quality Focus
Reports To:
Design Quality Engineering Manager
Location:
Austin, TX
Business Unit Description:
US Surgical
Job Title/High Level Position Summary:
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.
Key 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
Participating in Health Hazard Evaluations
Working on complex special projects as assigned
Minimum Basic Qualifications:
Bachelor's in Biomedical or Mechanical Engineering and 3+ years of experience, with at least 1 year in design focused environment (or equivalent combination of education and 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.
Travel Requirements:
Up to 10%
Desired Characteristics:
Preferred knowledge of the following software packages: Solidworks, Solidworks ePDM, Oracle R12, Agile PLM.
Prefer CQE, Lean, or 6 Sigma Certification.
Advanced knowledge of ISO 14971 and risk management principles
