Quality Engineer II

LKC Technologies has been a leader in functional eye testing solutions for over 45 years, focusing on practical and innovative tools for clinicians. Their handheld, portable RETeval® ERG/VEP device supports the diagnosis and management of conditions like diabetic retinopathy, optic nerve disorders, and retinal dystrophies. By delivering objective results without requiring corneal contact, LKC Technologies ensures efficient and patient-friendly assessments for eye health. Based on advanced technology, the company is committed to excellence in eye care diagnostics. Role Description: This is a full-time on-site role based in Germantown, MD. The Quality Engineer II will be responsible for developing and implementing quality control strategies, ensuring product quality, and maintaining high-quality assurance standards. The role involves overseeing quality processes, performing quality inspections, ensuring compliance with industry standards, and contributing to the improvement of quality management systems. Qualifications: Applicants must be currently authorized to work in the United States for any employer on a full‑time basis without the need for current or future visa sponsorship. Bachelor’s degree in a Scientific, Engineering, Quality Management, or a related field is required. Minimum 3 years’ experience in a quality engineering role in the medical, electronics packaging, or a related industry with manufacturing & assembly processes. Software/Firmware experience a plus. Strong expertise in Quality Engineering practices and methodologies. Experience in R&D NPI and Sustaining activities (design control, design reviews, technical documents, verification & validation, etc.). Proficient in Quality Control and Quality Assurance principles and techniques. Experience in ensuring Product Quality and optimizing production processes. Knowledge of Quality Management systems and standards (CAPA, training, risk management, NCR, audits (internal, external, supplier), DFMEA, PFMEA, doc/change control, PM, calibration, supplier management, etc.). Detail‑oriented with analytical and problem‑solving skills. Strong communication and collaboration abilities. Familiarity with regulatory requirements for medical devices is a plus. ISO 13485 Lead Auditor training is preferred. ASQ CQE preferred. Up to 20% travel to suppliers, as required. Responsibilities: Assists management in implementing and maintaining a quality system that is compliant with ISO 13485, FDA and other international quality system regulation requirements. Establishes monitoring method and maintenance tracking of Quality attributes: NCR/MRB, CAPAs, complaints, etc. Responsible for ensuring and/or performing final QC test and approval of finished goods. Responsible for managing the calibration of equipment and tools used for product development and manufacturing. Responsible for employee training execution and records. Responsible for quality control and maintenance of product technical documents. Evaluates changes to design and/or manufacturing process for quality impact. May lead and execute activities to close any gaps, such as additional verification testing or updates to risk documentation. Manage supplier quality (onboarding and sustaining). Evaluates supplier appropriateness, and audit suppliers, if required. Management of component, forms, procedures, and drawings databases. Ensures component part qualification activities, not limited to, but including: first articles, gage R&R, and implementation of SPC requirements are completed. Develops, documents, and validates inspection and test methods to support design control, in‑process inspection, and final inspection activities utilizing knowledge in engineering fields. Performs internal quality and design control audits. Performs product and process risk assessment activities, including hazard analysis and design/process failure modes & effects analysis (DFMEA/PFMEA). Assists in quality evaluation of returned products and supports RMA program as assigned. Leads, participates in, and/or coordinates Corrective Action initiatives as assigned. Participates in the technical review of design input specifications and design documentation for new and existing medical devices as assigned. Performs activities related to regulatory product registrations in various countries where LKC product may be sold. Additional support in quality services or quality systems activities as assigned #J-18808-Ljbffr