Quality Engineer

Job Purpose:

Responsible for quality oversight of the design, development, and production of medical device and combination products with focus on risk mitigation, phase appropriate design reviews, continuous improvement, and qualification strategy implementation.

Duties:

• 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.

Skills/Qualifications:

• Minimum:

1. Bachelor's degree in engineering, science, or relevant field
2. 0-5 years in regulated manufacturing and/or development environment
3. Proficiency with FDA 820 CFRs/ISO 13485/cGMP quality management system and requirements for medical devices and combination product development and manufacturing
4. Experience using risk analysis and continuous improvement concepts
5. Extensive experience with GxP requirements
6. Strong technical written and verbal communication skills
7. Experience leading and/or supporting audits

• Preferred:

1. Master's or advanced degree in relevant field
2. 5+ years in pharma or medical device manufacturing and/or development environment
3. Excellent interpersonal, change management, planning and organizational skills
4. Excellent oral, written, and presentation communication skills
5. GxP terminology, experience and working knowledge in phase appropriate environments ranging from pre-clinical to commercial
6. Project management experience
7. CQE ASQ or related certification

Personal Attributes:

• Meets Gilero Core Value: 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.