Enovis
Design Quality Engineer
USA, California, Carlsbad
Sponsorship not specifiedDetected 29 days ago
StatisticsProject ManagementExcelGD&TGMPFDA RegulatoryMedical DevicesCommunicationCollaborationWritingMicrosoft Office
About the role
- 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.
- By the way of example and not exclusion, process may include Standard Operating Procedures (SOP's) manufacturing processes, inspection procedure and test procedures.
Responsibilities
- The Design Quality Engineer will support priority Product Development and Sustaining Design Engineering projects as the lead Quality Engineering technical representative.
- This position will be responsible to assure product designs meet our compliance with FDA regulations, ISO 13485 and global regulatory standards and Company strategies.
- The position will report directly to the Manager of Design Quality.
- By the way of example and not exclusion, process may include Standard Operating Procedures (SOP's) manufacturing and design processes, inspection procedure and test procedures.
- Support, Review and Approve Design Specification packages
- Support, Review and Approve Material and Product Test Plans
- Review and Approve Design Engineering Drawings
- Review and Approve Design Verification and Validation Test Protocols and Reports
- Support Design Transfer activities: Develop inspection and testing methods, plans to perform First Article Approvals and lead execution of First Article inspections.
- Support Sustaining Design Quality Engineering Assignments, including ensuring verification and validation for design changes for product and process improvements, component end of life transition, and quality improvements.
Requirements
- Competent working knowledge of US and EU quality system regulations.
- Proven project management skills
- Ability to understand and interpret drawings and data - GD&T knowledge to interpret mechanical part drawings, assembly drawings, block and flow diagrams, and BOMs.
- Support Internal CAPA Program as required, including by example and not exclusion performing CAPA investigations and improvement implementation, verifying implementation and effectiveness of improvements.
Nice to have
- Bachelor's degree in Science or Engineering and 3 plus years of experience (CQA or RABQSA, CQE or CMfgE certification required)
- Certification may be obtained through successful completion of an RAB auditor course, successful completion of CQA (Certified Quality Auditor) or on-the-job training by another qualified internal auditor.
- Requires experience necessary to demonstrate the capability to carry out specialized technical/trade/craft procedure.
- May require regular use of speaking skills to discuss/explain semi-complex information or writing skills to communicated standard matters or procedures.
- Requires experience in biomedical engineering standards and concepts.
- Required knowledge of FDA/GMP, CMDR, MDD and ISO 13485 quality standards.
- Requires basic knowledge of manufacturing processes (and associated tools, instruments and test equipment) to include inspection, machine shop technology, polish/grind and clean room technology.
- Excel, or equivalent spreadsheet software.
Skills
- For more information about Enovis, please visit www.enovis.com.
Benefits
- Assists process owners to write and issue procedures to assure compliance with the current FDA QSR regulations, ISO 13485, CMDR and Medical Device Directive requirements
Company info
- 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.
- 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.
Equal 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.
This listing is sourced directly from Enovis's careers page and normalized into a canonical job model.