Senior Quality Inspector

Job Description

Job Description

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:   View email address on ziprecruiter.com

#KT