Senior Quality Inspector /

QC Lead Department:

Operations Reports To:

Director of Operations Functional Area:

Quality Location:

Boca Raton, FL Job Type:

Full-Time About the Role We are seeking an experienced Senior Quality Inspector / QC Lead to support and help develop our inspection and quality control function within a growing medical device manufacturing environment. This is a hands-on technical role responsible for incoming, in-process, RMA/returned product, and final inspection of medical instruments, components, and surgical trays. The position will also support inspection documentation, product acceptance and release, nonconformance activities, and broader Quality System initiatives. The ideal candidate combines strong dimensional inspection and measurement skills with practical quality experience and the ability to establish consistent, scalable inspection processes. This individual will serve as a technical resource for the inspection function and work closely with Operations, Manufacturing, Engineering, Supply Chain, and Quality. Key Responsibilities Perform incoming inspection of materials, components, instruments, and purchased products against engineering drawings, specifications, procedures, and inspection requirements. Perform first-piece and in-process inspections to verify critical dimensions, characteristics, workmanship, and assembly requirements. Perform final inspection of finished medical instruments and surgical trays, including configuration, quantity, identification, labeling, workmanship, and other specified requirements. Inspect RMA and returned products, accurately documenting product condition, findings, and potential failure characteristics. Perform dimensional and visual inspections using calipers, micrometers, gauges, and other precision measurement equipment. Interpret engineering drawings, specifications, and GD&T requirements. Identify, document, and segregate nonconforming product and provide objective inspection data to support product disposition and corrective action. Complete accurate and traceable inspection records, acceptance records, product- release documentation, DHRs, and other applicable quality records. Verify that required inspections and documentation are complete before product proceeds to the next operation or is released for shipment. Help develop and standardize inspection methods, work instructions, forms, sampling approaches, and acceptance criteria. Assist in selecting appropriate measurement equipment and inspection techniques for specific requirements. Identify recurring defects, supplier issues, process weaknesses, and opportunities to improve product quality and inspection effectiveness. Support Quality System activities, including nonconformance investigations, root- cause analysis, CAPA, internal audits, supplier quality, document control, and continuous improvement. Maintain proper use, care, identification, and calibration status of inspection and measurement equipment. Train and mentor inspectors and serve as a technical resource for the inspection function. Collaborate with Operations, Manufacturing, Engineering, Supply Chain, and Quality while maintaining objective and independent inspection decisions. Escalate quality concerns that may affect product conformity, patient safety, or regulatory compliance. Follow the company's Quality Management System and applicable FDA and

ISO 13485

requirements. Required Qualifications Candidates should meet one of the following education and experience combinations: Bachelor's degree in Quality, Engineering, Manufacturing, or a related technical field with 3+ years of relevant experience; OR Associate degree in a technical, manufacturing, engineering, or quality-related field with 5+ years of relevant experience; OR High school diploma or equivalent with 7+ years of progressive experience in quality inspection, quality control, or quality assurance within a regulated manufacturing environment. In addition, candidates must have: Strong experience with incoming, in-process, and final inspection. Proven ability to interpret engineering drawings and specifications. Strong dimensional inspection and precision measurement skills. Experience documenting inspection results and maintaining product traceability. Strong attention to detail and sound technical judgment. Ability to make objective, fact-based product acceptance decisions. Ability to identify and appropriately address nonconforming product. Preferred Qualifications Medical device manufacturing experience. Working knowledge of ISO 13485 and FDA Quality System requirements. Experience with CAPA, nonconformance, internal audits, supplier quality, document control, or other Quality System functions. Experience applying GD&T. Experience with CMMs, optical measurement systems, vision systems, or other advanced inspection equipment. Experience training or mentoring inspectors or quality personnel. ASQ or another recognized quality certification. Experience with ERP/MRP and Quality Management Systems. Experience with Fishbowl is a plus. Technical Skills Strong working knowledge of: Engineering drawings and specifications GD&T Dimensional inspection and precision measurement Calipers, micrometers, gauges, and related inspection equipment Inspection documentation and product traceability Nonconforming product processes Calibration requirements Quality records Quality Management Systems What We're Looking For The successful candidate will be: Technically strong and detail-oriented Objective, analytical, and fact-based Comfortable identifying and challenging nonconforming product Organized, dependable, and self-directed A strong communicator and collaborative team member Comfortable working directly with Manufacturing, Operations, Engineering, and Supply Chain Willing and able to train and mentor others A problem solver who looks beyond individual defects to identify systemic issues Comfortable working in a growing, hands-on, and changing environment About the Opportunity This position provides an opportunity to play a key role in strengthening inspection and quality capabilities within a growing medical device manufacturing organization. The Senior Quality Inspector / QC Lead will have a direct impact on product conformity, inspection effectiveness, process consistency, and the continued development of the Quality System. If you have strong hands-on inspection experience and want to help build and improve a quality function within a growing medical device organization, we'd like to hear from you.

Please email resume to:

Sheila@mykeystaff.com #KT