Quality Engineer-Medical Devices-Continuous Improvement

About the job

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.

Duties:
• Oversee the Supplier Management program including supplier qualification and on-going monitoring
• 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.
• Translate user input into measurable product requirements and specifications including incoming inspection 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.
• 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.
• Maintain quality records, summarize data, and report quality metrics to the organization.

Skills/Qualifications:

Minimum:
• 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.

Personal Attributes:
• Meets Gilero Core Values: Collaboration. Innovation. Excellence. 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.

Why work at Gilero?

Founded in 2002, Gilero, a Sanner Group company, is an international contract engineering firm that specializes in the design, development, and manufacturing of novel medical devices and drug delivery products. At Gilero we are proud of the culture we have built that directly reflects our values of excellence, integrity, innovation, and collaboration. Motivated by our purpose to benefit people and improve patient outcomes, our team continue to grow at a rapid pace. US locations include NC locations in Raleigh, Durham, Greensboro, and Pittsboro, as well as Chicago, IL, and Carlsbad, CA.

You will enjoy an annual bonus plan, Medical (3 BCBS plans to choose from), Guardian dental and vision, company provided short-term and long-term disability, 401(k) with a company match the first month you start with a zero-vesting period.