Design Quality Engineer

Design Quality EngineerThe Design Quality Engineer position is responsible to implement and lead Design Quality Engineering activities at the Enovis design and production location(s) as assigned. 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.Key Responsibilities: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; and to provide training to process owners related to Quality Management System requirements, as necessary.Support Design Quality Engineering Assignments, including New Product Introduction (NPI) projects, Corporate priority projects and sustaining support. Quality Engineering Responsibilities may include:Support, Review and Approve Design Specification packagesSupport, Review and Approve Material and Product Test PlansReview and Approve Design Engineering DrawingsReview and Approve Design Verification and Validation Test Protocols and ReportsSupport 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.Lead Risk Management process for assigned products and projects, coordinating development and implementation of risk management plans, hazard analyses, design and process failure modes and effects analyses (as applicable).Support Design History File establishment, creation, approval and maintenancePerform Design History File audits at Phase Gates to ensure product development projects are in compliance to applicable design control regulations and company policies and procedures.Coordinate Supplier Approvals for NPI projects with Supplier Quality Assurance in accordance with Enovis Supplier Approval process.Support, Review and Approve Design Transfer activities to ensure design quality performance requirements are properly transferred, which may include IQ, OQ, PQ, Process Validation, and updated Inspection Plans.Attend and support Project team meetings, collaboration sessions and other collaboration activities.Review and approve Change Orders required by process owners to write and issue procedures to assure compliance with the current FDA QSR regulations, ISO 13485, CMDR and Medical Device Directive requirements; and to provide training to process owners related to Quality Management System requirements, as necessary.Support Design Review and Change review meetings; review and decide disposition of obsolete revision materials.Support Cost of Poor Quality Initiative, by developing and executing site projects to reduce the costs associated with poor qualitySupport Enovis Corrective and Preventive Action ProcessLead Supplier Corrective Action program, communicating and coordinating CAPA completion of suppliers.Review CAPA assignment responses for completeness and validity.Support Internal CAPA Program as required, including by example and not exclusion performing CAPA investigations and improvement implementation, verifying implementation and effectiveness of improvements.Conduct internal audits:Conduct interviews, summarize observations, conduct closing meeting with Department SupervisorsEnter non-compliances into the Agile system and trend software, and follow-up with process owners until CAPA is closed.Assist in Notified Body Audits, FDA inspections and other 3rd party audits.Performs other duties as assigned by Management.Minimum Basic Qualifications:Bachelor's degree in Science or Engineering and 3 plus years of experience (CQA or RABQSA, CQE or CMfgE certification required)Requires certification to perform audits. 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.To perform this job successfully, an individual should have knowledge of Microsoft Word, or equivalent word processing software; Excel, or equivalent spreadsheet software. Statistical analysis and data base searches.Desired Characteristics:Competent working knowledge of US and EU quality system regulations.Proven project management skills; able to complete technical projects with minimal supervision. Strong interpersonal communication and teamwork skill.Ability to understand and interpret drawings and data – GD&T knowledge to interpret mechanical part drawings, assembly drawings, block and flow diagrams, and BOMs.