Senior Quality Engineer – Medical Devices

Key Responsibilities

• Review and approve change requests related to product, process, validation, and verification documentation
• Develop and maintain quality documentation including SOPs, quality plans, and inspection procedures
• Ensure compliance with FDA, ISO, and regulatory requirements, including 21 CFR Part 211 and/or Part 4
• Represent Quality in design reviews and cross-functional project discussions
• Perform gap analyses and ensure alignment of product requirements and verification documentation
• Review and approve validation activities including: Process Qualifications (IQ/OQ/PQ), Test Method Validations, Gage R&R and Process Capability Studies, Design of Experiments (DOE) and FMEAs
• Support CAPA, NCR, and complaint investigations, including root cause analysis and effectiveness checks
• Lead and support inspection and acceptance activities (FAI, in-process inspections, sampling plans)
• Apply statistical tools and methodologies (SPC, DOE, ANOVA) to drive quality improvements
• Collaborate with cross-functional teams to resolve quality issues and improve processes

Required Qualifications

• Bachelor's degree in Engineering or related field
• 6-8+ years of experience in Quality or Design Quality Engineering within medical devices
• Hands-on experience with combination products (drug-coated devices strongly preferred)
• Strong knowledge of 21 CFR Part 211 and/or Part 4
• Experience with process validation (IQ/OQ/PQ) and quality tools (SPC, DOE, FMEA, GR&R, CAPA)
• Solid understanding of FDA regulations and ISO standards (ISO 13485, 14971, 11607)
• Experience with CAPA ownership and quality event systems (e.g., NCEP)
• Strong analytical, problem-solving, and communication skills