Senior Quality Engineer – Medical Devices

Job Title:

Senior Quality Engineer Medical Devices

Location:

Arden Hills, MN - Onsite

We are seeking a Senior Quality Engineer with strong experience in combination products, particularly drug-coated medical devices. This role focuses on enhancing manufacturing processes, ensuring product quality, and maintaining compliance with regulatory standards.

The ideal candidate will bring deep expertise in quality systems, process validation, and regulatory compliance, along with hands‑on experience supporting products from development through commercialization.

• 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

• 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