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# Senior Design Quality Engineer - Medical Devices - Carlsbad, CA in Carlsbad

- **Company:** Energy Jobline
- **Location:** Carlsbad, CA, United States
- **Experience:** Expert
- **Contract:** Permanent contract
- **Skills:** Failure Mode Effects Analysis, Integrated Development Environments, Iq/oq/pq, GXP
- **Published:** September 4, 2026
- **Apply:** https://www.energyjobline.com/job/senior-design-quality-engineer-medical-devices-carlsbad-ca-carlsbad-31477021

## About the Role

* Able to work in the office at least 3 days a week
 * Bachelor's degree in engineering, science, or relevant field
 * 5+ years relevant work experience
 * Proficiency with FDA 820 CFRs/ISO 13485/cGMP quality management system and requirements for medical devices and/or combination product development and manufacturing
 * Proficiency with ISO 14971 and application of risk management to the development of medical devices and/or combination products
 * Experience with electromechanical medical devices and IEC 60601
 * Strong preference for experience in pharma or medical device manufacturing and/or development environment; Strong preference for electromechanical systems based experience
 * Experience using risk analysis and continuous improvement concepts
 * Experience with GxP requirements
 * Experience supporting audits
 * Strong technical written and verbal communication skills
 * Excellent interpersonal, change management, planning, and organizational skills
 * Excellent oral, written, and presentation communication skills

Personal Attributes:

 * Meets Gilero Core Values: Collaboration and Innovation of Excellence and Integrity
 * Productive in a fast-paced, entrepreneurial environment.
 * Commits to excellence and quality service to external and internal customers.
 * Adheres to established policies and procedures, while contributing to continuous improvements.

## Description

* Represent Quality in cross-functional development teams, providing direction for development through transfer to production activities.
 * Author, maintain, and ensure compliance of Design History File documents during the development process in accordance with ISO 13485.
 * Translate user needs, intended use, regulatory inputs, and risk controls into measurable product requirements, specifications, and acceptance criteria.
 * Support design verification and validation activities, including statistical approach and analysis
 * Support project related efforts with quality system elements (CAPA, Complaints, Supplier Management, External Audits, etc.).
 * Participate in and facilitate risk management activities (hazard analysis, FMEAs, and risk assessments per ISO 14971)
 * Ensure traceability and testability of design requirements and risk controls.
 * Support manufacturing transfer, including review of preparation and execution of process validation (IQ/OQ/PQ) protocols, and development of production inspection plans.
 * Investigate, disposition, and resolve nonconforming material events during product development And pre-production phases; support production phases for transferred programs as needed.
 * Act as technical expert (including potential author) for new or revised QMS procedures; May include train team members, and release quality system procedures, as required.
 * Support internal and external audits (particularly for projects), as required with help of broader quality management team
 * Support supplier selection, qualification, and ongoing monitoring with help of broader quality management team.
 * Facilitate investigations to determine root cause and failure modes.
 * Execute quality event initiation, investigation, and closure for nonconformances, CAPA, change control, and complaints as required.


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