QC Specialist

About the Role:

The QC Specialist plays a key role in ensuring Exalta products consistently meet customer specifications, internal quality requirements, and applicable medical device regulations. This position is responsible for performing inspections across incoming, in-process, and final stages, maintaining accurate inspection documentation, and supporting the control of nonconforming product. The QC Specialist works closely with Manufacturing, Engineering, Supply Chain, and Quality Assurance to identify defects, support investigations, and drive corrective actions that prevent recurrence.

This role directly supports Exalta's commitment to patient safety, product reliability, and regulatory compliance, while helping production teams improve yield, reduce waste, and maintain on-time delivery performance.

Minimum Qualifications:

• Bachelor's degree in Engineering, Manufacturing, Quality Assurance, or a related field.
• Minimum of 3 years of experience in quality control within a manufacturing environment.
• Working knowledge of quality systems and documentation practices (ex: ISO-based procedures, controlled forms, inspection records)
• Strong ability to read and interpret engineering drawings and specifications, including basic GD&T.
• Hands-on experience using inspection tools such as calipers, micrometers, height gages, pin/plug gages, optical comparator, or similar measurement equipment.
• Strong attention to detail with proven ability to document results accurately and consistently.
• Excellent analytical and problem-solving skills.

Preferred Qualifications:

• Experience in medical device manufacturing and regulated quality systems such as ISO 13485 and FDA 21 CFR Part 820.
• Familiarity with regulatory standards relevant to manufacturing, such as FDA or OSHA guidelines.
• Proficiency in using quality inspection tools and software. (Keyence, Starrett, Sylvac, MeasurLink)
• Experience with statistical process control (SPC) and root cause analysis methodologies.
• Strong communication skills for effective cross-department collaboration.
• Experience working with inspection sampling plans (AQL), first article inspection, and in-process control plans.
• Familiarity with nonconformance workflows (NCRs), MRB dispositions, and basic root cause tools (5 Why, Fishbone).
• Exposure to metrology methods such as CMM (Hexagon PC-DMIS) inspections, surface finish/profilometer readings, or other advanced measurement systems.
• Experience with ERP systems for inspection transactions and traceability (Epicor Kinetic strongly preferred).
• Certification(s) such as Certified Quality Inspector (CQI), Six Sigma Yellow/Green Belt, or equivalent

Responsibilities:

• Perform incoming inspection of raw material and purchased components, verifying documentation such as CoC, heat/lot traceability, and specification conformance. Conduct in-process inspections to support production quality and prevent downstream defects. Perform final inspection of finished goods prior to release, ensuring product meets print/spec requirements. Execute inspections using appropriate tools and methods based on work instructions, inspection plans, and risk level (sampling vs. 100% inspection).
• Accurately record inspection results in controlled inspection records and applicable systems (paper or electronic), maintaining strong data integrity and traceability. Support completion and accuracy of production documentation where required (ex: traveler verification, inspection forms, DHR-related documentation as applicable). Follow established procedures to ensure compliance with internal QMS requirements and applicable regulatory expectations.
• Identify, document, and segregate nonconforming material per procedure. Support NCR documentation including defect details, measurements, and evidence to assist Quality Engineering investigations. Assist in containment actions such as sorting/100% inspection when required, and support verification of rework effectiveness.
• Analyze quality data and generate reports to identify trends, defects, and areas for improvement within the manufacturing process.
• Collaborate with cross-functional teams including Manufacturing, Engineering, Supply Chain, and Quality Assurance to identify recurring defects, opportunities for process improvement, quality risks, and implement/execute corrective actions.
• Assist in improving inspection processes through better check methods, clearer acceptance criteria, and more efficient measurement approaches.
• Support training and coaching of production personnel on inspection techniques, workmanship expectations, and defect prevention mindset to foster a culture of continuous improvement.

Skills:

The QC Specialist utilizes analytical skills daily to interpret inspection data and identify quality trends that impact production outcomes. Attention to detail is essential when performing inspections and documenting findings to ensure accuracy and compliance. Communication skills are critical for effectively collaborating with production teams and training staff on quality standards. Problem-solving abilities are applied to investigate defects and implement corrective actions that improve product quality. Additionally, proficiency with quality management software and tools supports efficient data analysis and reporting, enabling informed decision-making.