QC Specialist

Job Summary:

The QC Engineer will be responsible for ensuring the quality of orthopaedic instruments and related medical devices through inspection, testing, and compliance with defined standards. The role requires hands-on experience in inspecting precision surgical instruments used across trauma, spine, and joint replacement procedures.

Product Scope (Instruments / Devices to be handled):

· Trauma Instruments: Bone plates instruments, screwdrivers, drill guides, taps, depth gauges, reduction forceps, bone holding forceps

· Spine Instruments: Pedicle screw instrumentation sets, rods, screwdrivers, distractors, compressors, trial instruments

· Hip & Knee Instruments: Reamers, rasps, broaches, alignment guides, cutting jigs, trial implants instruments

· Maxillofacial (CMF) Instruments: Mini plates instruments, screwdrivers, plate benders, cutters

· Implants (Basic QC Understanding): plates, screws, nails, cages (dimensional and visual inspection support)

Key Responsibilities:

· Perform incoming, in-process, and final inspection of above-mentioned Orthopedic instruments and devices

· Conduct dimensional inspection using Vernier calipers, micrometers, height gauges, gauges, and profile projectors

· Check fitment, assembly, and functional performance of surgical instruments

· Inspect surface finish, passivation, and corrosion resistance where applicable

· Maintain inspection reports and documentation as per ISO 13485 standards

· Identify non-conformities and implement CAPA

· Coordinate with production for quality improvements and rejection control

· Ensure calibration status of all measuring instruments

· Support audits and regulatory compliance activities

Key Skills & Competencies:

· Knowledge of orthopaedic instrument sets (Trauma, Spine, Arthroplasty, CMF)

· Strong understanding of precision measurement tools

· Knowledge of GD&T and engineering drawings

· Familiarity with ISO 13485 and GMP requirements

· Good analytical and documentation skills

Qualification & Experience:

· Education: Diploma / B.E. / B.Tech in Mechanical Engineering

· Experience: 2–5 years in QC of orthopedic instruments / medical devices