Quality Assurance Engineer

3 days ago

Austin, Texas, United States Enovis Full time
About Enovis

Enovis Corporation is a leading medical technology growth company dedicated to developing clinically differentiated solutions that generate measurably better patient outcomes and transform workflows.

Our company is powered by a culture of continuous improvement, global talent, and innovation, with an extensive range of products, services, and integrated technologies that fuel active lifestyles in orthopedics and beyond.

At Enovis, we strive to create better patient outcomes and transform workflows through our innovative solutions.

Job Title: Quality Assurance Engineer - Validation Focus

This role is responsible for utilizing comprehensive knowledge of engineering and problem-solving principles to design, implement, and maintain quality assurance procedures and work instructions to ensure external safety, quality, and compliance with complex Company standards and government regulations.

The Quality Assurance Engineer - Validation Focus will support operations and work closely with cross-functional teams to formulate and execute validations on equipment, processes, and software.

Key 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
Minimum Basic Qualifications:
  • Bachelor's in Science or Engineering and 3+ years of experience
  • Background in Medical Device, Aeronautics, Automotive, or other highly regulated industry required; preferred knowledge of ISO 13485 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:
  • Advanced knowledge of process, equipment, and software validation principles
  • Prefer CQE, Lean, or 6 Sigma Certification
  • Detail-oriented and analytical
Physical Requirements:
  • Ability to sit/stand for long periods of time
  • Ability to lift/pull/carry up to 25lbs

At Enovis, we strive to create better patient outcomes and transform workflows through our innovative solutions.

We offer a comprehensive benefits package, including medical insurance, dental insurance, vision insurance, spending and savings accounts, 401(k) plan, vacation, sick leave, and holidays.

We are an equal employment opportunity employer and strive to provide reasonable accommodation to employees' beliefs and practices that do not conflict with Enovis policies and applicable law.

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