Quality Control Technician (x2) (Lenexa, MSI)

In September 2024, Morgan Scientific Incorporated (MSI) joined the Vitalograph group of companies as a wholly owned subsidiary. Vitalograph - a global leader in respiratory diagnostics - has had a long and enduring relationship with Morgan Scientific. For both companies, the decision is a natural progression as the combined expertise allows the enlarged organisation to focus on delivering the best possible diagnostic solutions that can enable a better understanding of lung health.

The acquisition of Morgan Scientific is a key milestone in Vitalograph's plan to develop its respiratory diagnostics business globally, furthering its goal of providing comprehensive testing solutions that enable the best possible respiratory healthcare. Vitalograph is implementing an ambitious growth strategy and is on track to treble its respiratory diagnostics business in the four years leading to 2026.

Job Summary :

As a Quality Control (QC) Engineer, you will oversee the QC testing and inspection process from end to end for both inbound and outbound shipments of our respiratory diagnostic products. This role is responsible for implementing and further developing quality inspection and testing protocols to ensure that all equipment and components meet stringent industry standards before distribution to healthcare providers. Your expertise in quality control, testing, and compliance will be essential in maintaining our commitment to high-quality diagnostics that enable effective patient care.

Key Responsibilities :

• Quality Inspection : Conduct thorough inspections on all incoming medical equipment and components to verify adherence to quality standards, specifications, and regulatory requirements.
• System Testing : Verify that our respiratory diagnostic devices meet all functional, safety, and regulatory requirements by conducting comprehensive system testing, documenting all results.
• Documentation and Reporting : Maintain organized, accurate records of inspection & testing results identifying, documenting, and reporting discrepancies, quality issues, or non-conformances, and initiating corrective actions as needed.
• Analysing and Troubleshooting : Analyse system testing results with the ability to diagnose and resolve any quality issues found through systematic troubleshooting, ensuring functionality, safety, and compliance with quality standards.
• Order Fulfilment : Assist in the accurate and timely fulfilment of medical equipment orders by prioritizing and coordinating quality checks, documentation activities, and shipping logistics timelines to meet project deadlines.
• Process Improvement : Collaborate with internal teams to support continuous improvement initiatives to enhance quality control processes, ensuring consistent delivery of safe, high-quality, reliable medical equipment.
• Training and Mentorship : Train and mentor  other QC staff and testing support personnel, ensuring adherence to quality standards and fostering a culture of quality across the team.

Qualifications :

• Education : Bachelor's degree in quality management engineering, manufacturing, life sciences, or a related field, OR combined relevant experience paired with advanced certifications in quality management (e.g., Six Sigma, CQE).
• Experience :
• 3-5 years of experience in medical device space
• Experience with quality  management systems, quality control, and or testing within the medical device, healthcare, or diagnostics industry preferred.
• Strong background in QC protocols, equipment testing, and regulatory compliance is preferred.
• Technical Skills :
• Proficient in QC software and tools for testing, inspection, and data management preferred.
• Strong troubleshooting skills for electronic and mechanical devices, with the ability to interpret technical manuals and schematics.
• Familiarity with healthcare regulations and quality standards, including ISO 13485, ISO 90001, FDA QSR, and other relevant guidelines preferred.
• Analytical and Problem-Solving Skills : Strong ability to analyse test data, correlate results to defects, detect quality trends, and implement corrective actions to improve product quality.
• Communication and Leadership : Excellent written and verbal communication skills, with the ability to present findings and recommendations to senior leadership and mentor team members.

Working Conditions :

• Warehouse and Office Environment : Work is performed in both office and warehouse settings, with periods of standing and inspecting products in warehouse areas.
• Travel Requirements : Occasional travel may be required for quality audits or supplier inspections.