136 applicants
Gilero · 2 days ago
Quality Engineer
Triangle Area
Full-time
Hybrid
Mid Level
5+ years exp
Wonder how qualified you are to the job?
Maximize your interview chancesManufacturingMedical Device
Hiring Manager
Ted Mosler
Insider Connection @Gilero
Responsibilities
Represent the quality function in product development projects providing support for development and commercialization activities. Author design history file documents during the development process.
Translate user input into measurable product requirements and specifications.
Support design verification and validation activities, including authoring test protocols and reports.
Ensure compliant project documentation providing clear status and traceability in alignment with good documentation practices and controls hierarchy.
Manage, trend, and continuously improve assigned quality system element (CAPA, Complaints, Supplier Management, External Audits, etc.).
Participate in risk analysis assessments of medical devices.
Maintain accurate and complete Design History Files, including regulatory submission documents.
Assist with manufacturing transfer, including 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, pre-production, and production phases.
Author new or revised procedures, train team members and release quality system procedures, as required.
Support internal and external audits.
Support supplier selection, qualification, and on-going monitoring.
Facilitate investigations to determine root cause and failure modes.
Maintain quality records, summarize data, and report quality metrics to the organization.
Execute quality event initiation, investigation, and closure for nonconformance's, CAPA, change control and complaints. Perform effectiveness checks.
Qualification
Find out how your skills align with this job's requirements. If anything seems off, you can easily click on the tags to select or unselect skills to reflect your actual expertise.
Required
Bachelor's degree in engineering, science, or relevant field
0-5 years in regulated manufacturing and/or development environment
Proficiency with FDA 820 CFRs/ISO 13485/cGMP quality management system and requirements for medical devices and combination product development and manufacturing
Experience using risk analysis and continuous improvement concepts
Extensive experience with GxP requirements
Strong technical written and verbal communication skills
Experience leading and/or supporting audits
Preferred
Master's or advanced degree in relevant field
5+ years in pharma or medical device manufacturing and/or development environment
Excellent interpersonal, change management, planning and organizational skills
Excellent oral, written, and presentation communication skills
GxP terminology, experience and working knowledge in phase appropriate environments ranging from pre-clinical to commercial
Project management experience
CQE ASQ or related certification
Company
Gilero
Gilero specializes in designing and manufacturing devices for the medical and pharmaceutical industries.
51-200 employees
H1B Sponsorship
Gilero has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Trends of Total Sponsorships
2021 (1)
Funding
Current Stage
Growth StageTotal Funding
$4.49M2021-05-14Series Unknown· $4.49M
Leadership Team
Ted Mosler
Chief Executive Officer
Recent News
2024-01-20
Company data provided by crunchbase
