Job Description:
At Enovis™ we pay attention to the details. We embrace collaboration with our partners and patients and take pride in the pursuit 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. Why work at Enovis? See for yourself.
As a key member of the Quality Engineering 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 Systems Manager
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Reports To:
Sr Director, Quality Assurance
Location:
9800 Metric Blvd. Suite 100 Austin, TX 78758 United States of America
Business Unit Description:
QA Engineering - Austin
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.
Essential Duties and Responsibilities:
- Lead a small team of technicians and specialists responsible for QA compliance activities
- Develop, coach, attract, and retain top talent for the organization.
- Serves as the administrator and champion of the Surgical CAPA program
- Oversees the complaint handling unit at Surgical
- Chairs product quality team meetings
- Responsible for the development and maintenance of metric dashboards
- Process owner for health hazard evaluations, CAPA, Document Control, Complaints, Internal Audits,
- Performing analysis of reports and production data to identify trends.
- Initiating, developing and recommending updates or changes to quality standards and procedures.
- Assuring compliance to internal or external specifications and standards (i.e. GMP, ISO, FDA, CMDR).
- Reviewing trends in device failures associated with customer complaints and nonconforming materials.
- Leading root cause analysis.
- Leading in corrective and preventive action investigations.
- Support Manufacturing and Operations to remedy adverse quality or compliance situations.
- Working on complex special projects as assigned.
Qualifications:
- Bachelor's in science or engineering and 5+ years of experience.
- Supervisory experience preferred
- 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 on metrology, precision machining, grinding, product cleaning, and sterilization.
- Individuals should have knowledge of Microsoft Office Suite of software or equivalent.
Preferred knowledge of the following software packages: Solidworks, Solidworks ePDM, Oracle R12, Agile PLM.
Currently, Enovis does not provide sponsorship for employment visas (e.g., H-1B) and will not offer such sponsorship in the future. Applicants must already have full-time work authorization in the United States, both now and in the future, without requiring sponsorship
"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.
What does creating better together mean to us at Enovis? Discover the "why" behind our purpose, values and behaviors:
Our Enovis Purpose, Values and Behaviors on Vimeo
We offer a comprehensive benefits package that 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 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.
Join us in creating better together.
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.