Gilero, A Sanner Group Company · 18 hours ago
Senior Design Quality Engineer - Medical Devices
Triangle Area
Full-time
Hybrid
Senior Level
5+ years expGilero, A Sanner Group Company is an international contract engineering firm specializing in the design, development, and manufacturing of novel medical devices and drug delivery products. As a Senior Design Quality Engineer, you will ensure quality oversight of the design, development, and production of medical devices, focusing on risk mitigation and verification and validation strategies.
ManufacturingMedical DevicePharmaceuticalProduct Design
No H1B
U.S. Citizen OnlyHiring Manager
Tricia (Grabfelder) Lucas, MBA
Responsibilities
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
Qualification
Required
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 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
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
Applicants must be permanently authorized to work in the United States without the need for employer sponsorship now or in the future
Preferred
Experience with electromechanical medical devices and IEC 60601 preferred
Strong preference for experience in pharma or medical device manufacturing and/or development environment; Strong preference for electromechanical systems based experience
Benefits
Annual bonus plan
Medical (3 BCBS plans to choose from)
Guardian dental and vision
Company-provided life insurance
Short-term and long-term disability
401(k) with a match the first month you start with a zero-vesting period
Access to LinkedIn learning for personal and professional development
Company
Gilero, A Sanner Group Company
Gilero offers end-to-end device design, development and contract manufacturing in the medical and pharmaceutical industries.
51-200 employees
Funding
Current Stage
Growth StageTotal Funding
$4.49M2024-09-25Acquired
2021-05-14Series Unknown· $4.49M
Leadership Team
Ted Mosler
Chief Executive Officer
Recent News
Triad Business Journal
2025-01-01
2024-01-20
Company data provided by crunchbase