Quality Assurance Engineer -Validation

$73,000 - $126,000/Yr

DJO Global - Austin, TX

Full-time - Mid Level

Onsite - Austin, TX

Management of Companies and Enterprises

About the position

The Quality Assurance Engineer - Validation at Enovis plays a crucial role in ensuring the safety, quality, and compliance of medical technology products. This position involves designing, implementing, and maintaining quality assurance procedures and work instructions, while collaborating with cross-functional teams to validate equipment, processes, and software. The engineer will contribute to transforming patient care and improving outcomes in the medical technology industry.

Responsibilities

• Author and review validations for an orthopedic manufacturing facility
• Review and provide input to project plans for insourcing, new equipment, new cells, etc.
• Support Operations to remedy adverse quality or compliance situations
• Write and edit procedures, work instructions, and validation protocols and reports
• Author and review change orders for manufacturing changes and assess requirements
• Work on complex special projects as assigned

Requirements

• Bachelor's degree in Science or Engineering
• 3+ years of experience in a relevant field
• Background in Medical Device, Aeronautics, Automotive, or other highly regulated industry
• Preferred knowledge of ISO 13485 quality standards
• Knowledge of technical writing quality and best practices
• Basic knowledge of manufacturing processes, focusing on metrology, precision machining, grinding, product cleaning, and sterilization
• Familiarity with Microsoft Office Suite or equivalent

Nice-to-haves

• Advanced knowledge of process, equipment, and software validation principles
• CQE, Lean, or 6 Sigma Certification
• Detail-oriented and analytical

Benefits

• Medical Insurance
• Dental Insurance
• Vision Insurance
• Spending and Savings Accounts
• 401(k) Plan
• Vacation, Sick Leave, and Holidays
• Income Protection Plans
• Discounted Insurance Rates
• Legal Services