Design Quality Engineer

Job Overview

Job Title:

Design Quality Engineer

Reports To:

Director, QA | QC

Location:

Carlsbad, CA (Hybrid 3 days onsite 2 days remote)

Business Unit:
Bracing & Supports

• 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. Example procedures include Standard Operating Procedures (SOPs) for manufacturing and design processes, inspection procedures and test procedures.
• Reviews and approves completed procedures to assure compliance with content and regulatory requirements.
• Supports Design Quality Engineering assignments, including New Product Introduction (NPI) projects, corporate priority projects and sustaining support.
• Supports, reviews and approves Design Specification packages, Material and Product Test Plans, Design Engineering Drawings, and Design Verification and Validation Test Protocols and Reports.
• Supports Design Transfer activities: develops inspection and testing methods and plans to perform First Article Approvals and leads execution of First Article inspections.
• Supports sustaining Design Quality Engineering assignments by ensuring verification and validation for design changes, component end‑of‑life transition and quality improvements.
• Leads the Risk Management process for assigned products and projects, coordinating development and implementation of risk management plans, hazard analyses, and failure modes and effects analyses (as applicable).
• Supports Design History File establishment, creation, approval and maintenance; performs Design History File audits at Phase Gates to ensure compliance with applicable design control regulations and company policies.
• Coordinates Supplier Approvals for NPI projects with Supplier Quality Assurance per Enovis Supplier Approval process.
• Supports, reviews and approves Design Transfer activities to ensure design quality performance requirements are properly transferred, which may include IQ, OQ, PQ, Process Validation and updated Inspection Plans.
• Attends and supports project team meetings, collaboration sessions and other collaboration activities.
• Supports Design Review and Change Review meetings; reviews and decides disposition of obsolete revision materials.
• Supports the Cost of Poor Quality Initiative by developing and executing site projects to reduce costs associated with poor quality.
• Leads the Enovis Corrective and Preventive Action Process, communicates and coordinates CAPA completion of suppliers, and reviews CAPA assignment responses for completeness and validity.
• Supports the internal CAPA program, performs CAPA investigations and improvement implementation, and verifies implementation and effectiveness of improvements.
• Conducts internal audits: performs interviews, summarizes observations, conducts closing meetings with department supervisors, enters non‑compliances into the Agile system and trend software, and follows up until CAPA is closed.
• Assists in Notified Body Audits, FDA inspections and other third‑party audits.
• Performs other duties as assigned by management.

• Bachelor’s degree in Science or Engineering and 3+ years of experience; CQA or RABQSA, CQE or CMfgE certification required.
• Certification to perform audits obtained through completion of an RAB auditor course, successful completion of CQA (Certified Quality Auditor) or on‑the‑job training by another qualified internal auditor.
• Experience necessary to demonstrate capability to carry out specialized technical/trade/craft procedures.
• Regular use of speaking skills to discuss or explain semi‑complex information, and writing skills to communicate standard matters or procedures.
• Experience in biomedical engineering standards and concepts.
• Knowledge of FDA/GMP, CMDR, MDD and ISO 13485 quality standards.
• Basic knowledge of manufacturing processes, including inspection, machine shop technology, polish/grind and clean room technology.
• Proficiency with Microsoft Word, Excel or equivalent word processing and spreadsheet software;…