Medical Device Quality Assurance Engineer
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Job Location:
Austin, TX - USA
Monthly Salary:
Not Disclosed
Posted on:
23 days ago
Vacancies:
1 Vacancy
Job Summary
Who We Are
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 Companys extensive range of products services and integrated technologies fuels active lifestyles in orthopedics and more information about Enovis please visit .
What Youll Do
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 thats how we change the lives of patients for the better. And thats how we create better together. Why work at Enovis See for yourself.
As a key member of the Quality 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:
Medical Device Quality Engineer
Reports To:
Sr Manager Quality Engineering
Location:
Austin Texas
Business Unit Description:
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/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 directly supports Operations/Manufacturing and serves as the QA representative on the Material Review Board.
Key Responsibilities:
- Evaluating Nonconforming material and dispositioning based on cross-functional engineering review
- Performing analysis of reports and production data to identify trends.
- Initiating developing and recommending updates or changes to quality standards and procedures.
- Authoring and conducting process and equipment validations
- 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.
Minimum Basic Qualifications:
- Bachelors in Science or Engineering 3-5 years of experience.
- Experience with manufacturing transfers and validation (IQ/OQ/PQ) in a regulated environment required.
- 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.
- Preferred knowledge of the following software packages: Solidworks Solidworks ePDM Oracle R12 Agile PLM.
- Prefer CQE Lean or 6 Sigma Certification
Desired Characteristics:
- Accurate and professional telephone communication
- Accurate and professional written communication (email text and formal letter)
- Position is office based (Austin TX)
- Must be able to lift 50 lbs.
- Must be able to bend twist and lift overhead.
- Must possess professional ethics and demeanor
- Must demonstrate excellent customer service.
- Computer skills (Excel Word Power Point).
- Must be able to communicate in English clearly and fluently in both written and verbal skills
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. Its the Enovis purpose and its 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
Join us in creating better together.
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.
Required Experience:
IC
Key Skills
About Company
At Enovis, we develop clinically differentiated medical technology solutions that generate measurably better patient outcomes and transform workflows. Our brands include Aircast, Chattanooga, CMF, Compex, Enovis Surgical, DonJoy, Dr. Comfort, Exos and Procare.
