Grove Technical Resources is looking for Principal Quality Engineer - Medical Device - W2 (Waukegan) in Beach Park, IL.
This local job opportunity with ID 3898439977 is live since 2026-10-18 14:29:58.
Job Title: Senior / Principal Quality Engineer – FDA Remediation Job Type: Contract – Initial 6 Months, Potential Extension Location: Glens Falls, NY | Waukegan / Mundelein / Northfield, IL Work Arrangement: Hybrid Job Description: We are seeking experienced Senior / Principal Quality Engineers to support FDA compliance and remediation programs within a regulated medical device or pharmaceutical manufacturing environment. Candidates must be hands-on, capable of independently executing CAPA activities, remediating quality documentation, and driving compliance actions through closure. Key Responsibilities: Execute CAPA and FDA remediation activities according to established plans. Review and remediate Risk Management Files, Design History Files (DHF), and design control documentation. Review technical files, test reports, validation protocols, and historical product records. Update SOPs, procedures, work instructions, and Quality System documentation. Identify documentation gaps and implement corrective actions. Collaborate with Quality, Engineering, Manufacturing, and Regulatory teams. Track remediation deliverables and meet FDA commitment deadlines. Required Skills: Senior-level Quality Engineering / Quality Systems experience CAPA execution and closure FDA compliance and remediation Medical Device / Pharmaceutical / Regulated Manufacturing Quality Management Systems (QMS) Technical Documentation Review and Remediation Strong Technical Writing and Problem-Solving Skills Preferred Skills: Risk Management Files and Design History Files (DHF) Design Controls and FDA Warning Letter Remediation Manufacturing Quality and Validation Documentation Legacy Medical Device / Product Remediation SOP and Quality System Remediation Education: Bachelor's degree in Engineering, Science, Quality, or a related technical field.5c143e31-5e48-4549-b638-05792d185386
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