Medical Device Manufacturing Engineer

Overview We are seeking a hands-on quality assurance engineer with strong manufacturing, root-cause analysis, and quality systems experience. This hybrid Quality/Manufacturing role owns key elements of the Quality Management System (QMS), including Nonconformance Management, Equipment Qualification/Calibration, Incoming and In-Process Inspection, and Supplier Quality, while contributing to improving product quality, cost, and manufacturability. Responsibilities Lead investigations and manage dispositions for all manufacturing nonconformances.

Review, optimize, and validate manufacturing processes for quality and regulatory compliance. Own tooling and equipment qualification and calibration. Manage supplier quality, including evaluations, audits, and SCARs.

Drive internal CAPAs tied to manufacturing issues. Track production data, identify trends, and drive continuous improvement efforts. Train and support the team on QMS processes, GMP, and process controls.

Maintain and improve manufacturing documentation, inspection procedures, and Device History Records. Required Qualifications Bachelor’s degree in Manufacturing, Mechanical, Biomedical, or Industrial Engineering; or 8+ years of relevant experience. 3+ years in a regulated environment (medical devices preferred). Clear, concise technical writing skills.

Working knowledge of QMS elements such as CAPA, Training, Nonconformance, and Change Control. Familiarity with ISO 13485. Comfortable supporting internal and external audits.

Skills That Will Make You Successful Practical experience in manufacturing and quality engineering. Detail-oriented mindset with a focus on mistake-proofing. Solid engineering fundamentals: materials, manufacturing, test methods, and root cause analysis.

Clear communicator with both technical and nontechnical stakeholders. Collaborative team player and proactive problem solver. The company provides a comprehensive benefits package, including medical insurance , dental reimbursement , 15 days of paid time off (PTO) plus federal holidays, and a 401(k) plan with both pre-tax and Roth options. #J-18808-Ljbffr