About the Job:
As a Senior Quality Engineer at Gilero, you'll play a crucial role in ensuring the quality of medical devices and combination products that make a difference in the lives and health of patients. You will be responsible for quality oversight of the design, development, and production of medical device and combination products with focus on systematic continuous improvement in the areas of risk mitigation, phase appropriate design reviews and qualification strategy implementation.
Join us in a collaborative and innovative environment where your contributions will make a real difference. You'll work with multiple disciplines and clients across a variety of products to help shape the future of healthcare technology, ensuring products meet the highest standards and positively impact patient outcomes across the globe.
Responsibilities:
- Represent the quality function in product development projects providing direction for development and commercialization activities.
- Author design history file documents during the development process.
- Translate user input into measurable product requirements and specifications.
- Lead design verification and validation activities, including authoring test protocols and reports.
- Manage, trend, and continuously improve assigned quality system element (CAPA,
- Complaints, Supplier Management, External Audits, etc.).
- Lead risk analysis assessments of medical devices.
- Maintain accurate and complete Design History Files, including regulatory submission documents.
- Facilitate 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.
- Lead internal and external audits.
- Lead supplier selection, qualification, and on-going monitoring.
- Lead 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 nonconformances, CAPA, change control and complaints. Perform effectiveness checks.
Skills/Qualifications:
Minimum:
- Bachelor's degree in engineering, science, or relevant field
- 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/or 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:
- Experience with electromechanical medical devices and IEC 60601
- Strong preference for experience in pharma or medical device manufacturing and/or development environment
- Master's or advanced degree in relevant field
- 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, Integrity, Innovation, Excellence
- Comfortable and productive in a fast-paced, entrepreneurial environment
- Commitment to excellence and quality service to external and internal customer
- Commitment to established policies and procedures, while contributing to continuous improvements
