Senior Quality Engineer - Continuous Improvement

About the Role

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. Join us in a collaborative and innovative environment where your contributions will make a real difference.

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.

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.

Preferred Qualifications

• 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.

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.

Eligibility

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).

Benefits

• Annual bonus plan.
• Medical (3 BCBS plans to choose from), dental, and vision insurance.
• 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.