Job Description:
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:
Manufacturing Quality Assurance Engineer - Validation Focus
Reports To:
Quality Program Manager - Operations
Location:
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Austin, TX
Business Unit Description:
US Surgical
Job Title/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
- Working 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.
Travel Requirements:
- Up to 10%
Desired Characteristics:
- Advanced knowledge of process, equipment, and software validation principles
- Knowledge of technical writing quality and best practices.
- Knowledge of ISO 13485 quality standard.
- 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.
- 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
"Creating better together". It's the Enovis purpose, and it's what drives us and empowers us every day on a global scale. We know that the power to create better - for our customers, our team members, and our shareholders - begins with having the best team, pursuing common goals, operating at the highest levels, and delivering extraordinary outcomes.
Watch this short video and discover what creating better together means to us at Enovis:
Our Enovis Purpose, Values and Behaviors on Vimeo
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.
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. For more information about Enovis, please visit www.enovis.com.
EOE AA M/F/VET/Disability Statement
All qualified applicants will receive consideration for employment and will not be discriminated against on the basis of race, religion, color, national origin, sex, protected veteran status, disability, or any other basis protected by federal, state or local laws.