lity is everyone's responsibility, and you will set the standard for how we build quality into our products, processes, and our people by being a player-coach within your team and with the cross-functional teams you support.
Essential Duties and Responsibilities:
The following are the primary duties and responsibilities of this role. Other related duties may be assigned to meet the business need.
Lead the team of Quality NPI engineers to ensure they are supporting their cross functional team members by owning all Quality aspects of NPI projects (QMS and Business Processes).
Be a player-coach by understanding, supporting, and owning the NPI Quality Engineering Project Responsibilities listed below.
Understand and facilitate compliance with quality standards and procedures needed to bring new products to market.
Ensure our quality standards and procedures are in compliance with internal or external specifications and standards such as GLP, GMP, ISO, etc.
Partner and collaborate with mid- to senior-level management on behalf of the Quality organization to ensure your teams views are being heard and that the NPI cross functional teams are being adequately supported.
Own project resourcing processes by allocating Quality NPI resources as appropriate, identifying any gaps in resources, training, or responsibilities, and communicating assignments and expectations to the team and to the Quality leadership team.
Ability to support more than one new product development project in different development phases.
Have a professional disposition which promotes a culture of quality, early in the development cycle and pushes quality upstream.
Cleary and concisely communicate ideas, solutions, or issues with cross functional team and with leadership.
Ability to drive decision making by listening to the team's inputs, asking the right questions, and driving to effective solutions.
Hold groups and individuals accountable and committed by clearly stating needs and communicating priorities associated with project strategy, needs and tasks.
NPI Quality Engineering Project Responsibilities
Cross Functional Project Team
Support Sustaining Quality Engineers by learning from the issues they face while maintaining legacy product and work to improve our processes, procedures, and products during the NPI process.
Required Education and Experience:
Bachelor's degree in Engineering or similar discipline; equivalent combination of education and experience may be considered.
5+ years of Quality Engineering experience in medical technology
2+ years leading a team preferred
Experience with NPI/NPD Quality Engineering and Design Controls
Experience with Risk Management (ISO 14971) and dFMEAs
Experience with design transfer from R&D into manufacturing and experience working on design changes
Competency in Microsoft office suite (Word, Excel, PowerPoint, etc), SolidWorks, SolidWorks PDM, and statistical software applications such as Minitab.
Demonstrated familiarity with gauging methods, techniques and strategies such as attribute and variable gages, CMM programming, tolerance application and metrology equipment.
Gage design experience is beneficial.
Inspection experience is beneficial.
Manufacturing experience is beneficial.
"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:
Spending and Savings Accounts
Vacation, Sick Leave, and Holidays
Income Protection Plans
Discounted Insurance Rates
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 https://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.
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 https://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.