Quality Assurance Engineer - Operations
Company: Enovis
Location: Austin
Posted on: April 30, 2024
Job Description:
Job Description:Job DescriptionAt 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 - Operations FocusReports To:Quality
DirectorLocation:Austin, TXBusiness Unit Description:US SurgicalJob
Title/High Level Position Summary:
- Utilizing a 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.
- 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:
- 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 ISO13485
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:
- Preferred knowledge of the following software packages:
Solidworks, Solidworks ePDM, Oracle R12, Agile PLM.
- Prefer CQE, Lean, or 6 Sigma Certification.
- Detail oriented and analyticalPhysical 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: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 ServicesABOUT ENOVISEnovis 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 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 ENOVISEnovis 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 .EOE AA M/F/VET/Disability
StatementAll 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.
Keywords: Enovis, Temple , Quality Assurance Engineer - Operations, Engineering , Austin, Texas
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