Quality Assurance Engineer - Validation

Job Description :

Increase your chances of an interview by reading the following overview of this role before making an application.

At Enovis we sweat the little things. We embrace collaboration with our partners and patients, and we glory in the grind of scientific excellence - with the goal of transforming medical technology as we know it.

Because that's how we change the lives of patients for the better. And that's how we create better together.

As a key member of the Quality Assurance team, you will play an integral part in helping Enovis drive the medical technology industry forward through transforming patient care and creating better patient outcomes.

Job Title :

Quality Assurance Engineer - Validation Focus

Reports To :

Quality Program Manager - Operations

Location : Austin, TX

Austin, TX

Business Unit Description :

US Surgical

High Level Position Summary :

• Utilizing 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 supports operations and works 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

We offer a comprehensive benefits package which includes :

• 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

ABOUT ENOVIS :

Enovis Corporation (NYSE : ENOV) is an innovation-driven medical technology growth company dedicated to developing clinically differentiated solutions that generate measurably better patient outcomes and transform workflows.

Powered by a culture of continuous improvement, global talent and innovation, the Company's extensive range of products, services and integrated technologies fuels active lifestyles in orthopedics and beyond.

Visit www.enovis.com to learn more.

EQUAL EMPLOYMENT OPPORTUNITY :

Enovis provides equal employment opportunities based on merit, experience, and other work-related criteria and without regard to race, color, ethnicity, religion, national origin, sex, age, pregnancy, disability, veteran status, or any other status protected by applicable law.

We also strive to provide reasonable accommodation to employees' beliefs and practices that do not conflict with Enovis policies and applicable law.

We value the unique contributions that every employee brings to their role with Enovis.

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