Senior Quality Inspector

Company Description

SurGenTec® is a privately owned medical device company based in Boca Raton, Florida, dedicated to developing intuitive technologies that elevate the standard of care in spine and orthopedic surgery. With surgeon and patient safety at the core of our mission, we design and manufacture minimally invasive solutions that simplify procedures and improve outcomes.

Our team works closely with Healthcare Professionals and global partners to create innovative technologies that improve procedural efficiency and precision. We focus on continuous improvement, using real-world feedback to refine our designs and deliver practical, forward-thinking solutions that make a difference.

Founded in 2016, SurGenTec® is committed to delivering reliable, surgeon-friendly technologies that support better patient care and drive progress in modern surgical practice.

Position Summary

SurGenTec is 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 position responsible for incoming, in-process, RMA/returned product, and final inspection of medical instruments, components, and surgical trays prior to shipment. The position will also support inspection documentation, product acceptance and release, nonconformance activities, and broader Quality System initiatives.

The ideal candidate will bring strong technical inspection skills combined with practical Quality experience and the ability to help establish consistent, scalable inspection processes. This individual will serve as a technical resource to 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 product against drawings, specifications, procedures, and inspection requirements.
• Perform in-process and first-piece inspections to verify critical dimensions, characteristics, workmanship, and assembly requirements.
• Perform final inspection of finished instruments and surgical trays, including configuration, quantity, identification, labeling, workmanship, and other specified requirements.
• Perform RMA/returned product inspections and accurately document condition, findings, and potential failure characteristics.
• Perform dimensional and visual inspections using appropriate precision measurement equipment and techniques.
• Interpret engineering drawings, specifications, and GD&T requirements.
• Identify, document, and segregate nonconforming product and provide objective inspection information to support disposition and corrective action.
• Complete accurate and traceable inspection records, acceptance records, and product-release documentation;
  support DHR and other applicable quality records.
• Ensure required inspection activities and documentation are complete before product proceeds to the next operation or is released for shipment.
• Help develop and standardize inspection methods, inspection instructions, forms, sampling approaches, and acceptance criteria.
• Assist in determining appropriate measurement equipment and techniques for specific inspection requirements.
• Identify recurring defects, supplier issues, process weaknesses, and opportunities to improve product quality and inspection effectiveness.
• Support Quality 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 developing inspection function.
• Work collaboratively 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 SurGenTec's Quality Management System and applicable FDA and ISO 13485 requirements.

Qualifications Required

• Bachelor's degree in Quality, Engineering, Manufacturing, or a related technical field with a minimum of 3 years of relevant experience;
  OR
• Associate degree in a technical, manufacturing, engineering, or quality-related field with a minimum of 5 years of relevant experience;
  OR
• High school diploma or equivalent with a minimum of 7 years of progressive experience in quality inspection, quality control, or quality assurance within a regulated manufacturing environment.
• Strong experience with incoming, in-process, and final inspection.
• Proficiency interpreting engineering drawings and specifications.
• Strong dimensional inspection and precision measurement skills.
• Experience documenting inspection results and maintaining product traceability.
• Strong attention to detail, judgment, and ability to make objective, fact-based decisions.

Preferred

• 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 with 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 other recognized quality certification.

Technical Skills

Strong working knowledge of:

• Engineering drawings and specifications
• GD&T
• Precision measurement and dimensional inspection
• Calipers, micrometers, gauges, and related inspection equipment
• Inspection documentation and traceability
• Nonconforming product processes
• Calibration requirements
• Quality records

*Experience with ERP/MRP and Quality Management Systems is preferred;
Fishbowl experience is a plus.

Key Attributes

The successful candidate will be:

• Technically strong and detail-oriented
• Objective and fact-based
• Comfortable identifying and challenging nonconforming product
• Organized and self-directed
• A strong communicator and team player
• Comfortable working directly with Manufacturing, Operations and Engineering
• Willing to train and mentor others
• A problem solver who looks beyond individual defects to identify systemic issues
• Comfortable working in a growing and changing environment

Salary range from $70K to $80k DOE + Benefits

Please send resumes to: View email address on click.appcast.io

Notice to Recruiters and Staffing Agencies: SurGenTec manages all recruiting for this position internally and is not seeking agency support. We do not accept unsolicited resumes from third-party recruiters, search firms, or staffing agencies. Any resumes submitted without a signed agreement in place prior to submission will be considered the property of SurGenTec, and no fee will be paid if we hire from those submissions. Recruiters are asked not to contact the job poster, hiring manager, or any SurGenTec employees regarding this role. Candidates, please apply directly through this posting.