Senior Quality Engineer - Continuous Improvement

GILERO•Durham, NC

6d•Hybrid

About The Position

Are you passionate about working to create high-quality, innovative medical and drug delivery devices to improve lives? As a Quality Engineer at Gilero, you’ll play a crucial role in ensuring the quality of life impacting medical devices and combination products. In this role you will provide oversight of the supplier management program and ensure continuous improvement of quality systems while supporting the design, development, and production of medical device and combination products. This position can be based in our Durham Office or our Pittsboro Manufacturing Plant with options for hybrid work. Come join us and work in a collaborative and innovative environment where your contributions of ensuring products meet high standards will make a real difference.

Requirements

Bachelor's degree in engineering, science, or relevant field.
Minimum of 5 years quality experience in a 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.
Excellent interpersonal, change management, planning and organizational skills.
Excellent oral, written, and presentation communication skills.
Applicants must be permanently authorized to work in the United States without the need for employer sponsorship now or in the future.
Gilero does not offer sponsorship for employment authorizations (work visas).
We are an E-Verify employer and confirm work authorization for all new hires.

Nice To Haves

Master's or advanced degree in relevant field.
5+ years in pharma or medical device manufacturing and/or development environment.
GxP terminology, experience and working knowledge in phase appropriate environments ranging from pre-clinical to commercial.
Project management experience.
CQE ASQ or related certification.

Responsibilities

Drive continuous improvement in quality and production processes by proactively identifying opportunities for improvement and developing action plans
Manage, trend, and continuously improve assigned quality system elements (CAPA, Complaints, Supplier Management, External Audits, etc.).
Execute quality event initiation, investigation, and closure for nonconformances, CAPA, change control and complaints. Perform effectiveness checks.
Facilitate investigations to determine root cause and failure modes.
Author new or revised procedures, train team members and release quality system procedures, as required.
Support internal and external audits including customer and supplier audits
Represent the quality function in product development projects providing support for development and commercialization activities. Author design history file documents during the development process.
Ensure compliant project documentation providing clear status and traceability in alignment with good documentation practices and controls hierarchy.
Investigate, disposition, and resolve nonconforming material events during product development, pre-production, and production phases.
Maintain quality records, summarize data, and report quality metrics to the organization.