Enovis
Manufacturing QA Engineer-Verification
Enovis, Austin, Texas, us, 78716
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 :Quality Assurance Engineer - Inspection FocusReports To :Quality Manager - Metrology and Quality Control
Location: 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 provides quality support to the Enovis instrument re-sourcing initiative focused on increasing offshore supplier contribution to our instrument needs This position also supports the incoming inspection department by working closely with Enovis' instrument suppliers and internal teams to reduce inspection burden while ensuring high product quality.Key Responsibilities :Review inspection strategies and inspection techniques used by Enovis on implant and instrument product
Review CMM programs for suitability
Partner with suppliers to develop their inspection to an extent that they are certified to perform the final inspection in lieu of Enovis
Author and execute supplier inspection certifications and validations
Conduct process capability PQs to reduce inspection
Analyzing protocols and reports to ensure quality system requirements are met
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.
Prior background in Medical Device, Aeronautics, Automotive or other highly regulated industry required;
Must hold a valid passport and be able to travel internationally without restrictions.
Travel Requirements:Up to 20%
Desired Characteristics :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.
Knowledge of CMM programming
Preferred knowledge of the following software packages: Solidworks, Solidworks ePDM, Oracle R12, Agile PLM, and PC-DMIS
Prefer CQE, Lean, or 6 Sigma Certification.
Advanced knowledge of mechanical inspection and the associated inspection equipment
Detail oriented and analytical
Physical Requirements:None
"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 VimeoWe 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 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 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 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 www.enovis.com.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.
Location: 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 provides quality support to the Enovis instrument re-sourcing initiative focused on increasing offshore supplier contribution to our instrument needs This position also supports the incoming inspection department by working closely with Enovis' instrument suppliers and internal teams to reduce inspection burden while ensuring high product quality.Key Responsibilities :Review inspection strategies and inspection techniques used by Enovis on implant and instrument product
Review CMM programs for suitability
Partner with suppliers to develop their inspection to an extent that they are certified to perform the final inspection in lieu of Enovis
Author and execute supplier inspection certifications and validations
Conduct process capability PQs to reduce inspection
Analyzing protocols and reports to ensure quality system requirements are met
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.
Prior background in Medical Device, Aeronautics, Automotive or other highly regulated industry required;
Must hold a valid passport and be able to travel internationally without restrictions.
Travel Requirements:Up to 20%
Desired Characteristics :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.
Knowledge of CMM programming
Preferred knowledge of the following software packages: Solidworks, Solidworks ePDM, Oracle R12, Agile PLM, and PC-DMIS
Prefer CQE, Lean, or 6 Sigma Certification.
Advanced knowledge of mechanical inspection and the associated inspection equipment
Detail oriented and analytical
Physical Requirements:None
"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 VimeoWe 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 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 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 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 www.enovis.com.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.