Quality Manager

Pay Rate:
Based on Experience (Flexible for Top Candidates) 100,000 to 130,000

Type:
Direct Hire

Schedule: 1st Shift

We are seeking a hands-on Quality Manager to join a growing Medical Device manufacturing company in Trumbull, CT. This leadership role will oversee the Quality Assurance, Quality Control, and Metrology functions while ensuring compliance with ISO 9001:2015 and ISO 13485:2016 standards.

The ideal candidate will come from a Medical Device, Precision Manufacturing, Machining, or Stamping environment and have strong experience leading quality systems, audits, CAPA activities, inspections, validations, and continuous improvement initiatives in a fast-paced manufacturing setting.

• Lead and manage the Quality Department including Quality Engineers, QC Inspectors, and Metrology personnel
• Oversee daily Quality Assurance and Quality Control activities across manufacturing operations
• Ensure compliance with ISO 9001:2015 and ISO 13485:2016 standards
• Manage internal, customer, supplier, and third-party audits
• Lead CAPA investigations, root cause analysis, corrective and preventive actions
• Oversee calibration systems, metrology labs, and inspection equipment compliance
• Support APQP, PPAP, pFMEA, Gage R&R, capability studies, and First Article Inspections
• Manage CMM and VMM inspection programming activities
• Review and approve quality documentation, control plans, SOPs, validation documents, and work instructions
• Partner closely with Engineering, Manufacturing, Operations, and Supply Chain teams to improve product quality and manufacturing performance
• Support prototype inspections, validations, supplier approvals, and Supplier Change Requests (SCRs)
• Drive continuous improvement and Lean Manufacturing initiatives throughout the facility
• Analyze quality data and metrics using statistical tools and implement corrective actions as needed
• Serve as the primary quality contact for customer quality concerns, complaints, and audit activities
• Train, mentor, and develop Quality team members while promoting a strong quality culture throughout the organization

• Bachelor’s Degree in Engineering, Quality, Manufacturing, or related technical field preferred
• 5+ years of Quality Management or Senior Quality Engineering experience within Medical Device or regulated manufacturing environments
• Strong understanding of:
• ISO 9001:2015
• ISO 13485:2016
• CAPA Systems
• Audits and Compliance
• Calibration and Metrology
• Validation Processes
• Experience managing Quality Engineers, Inspectors, and/or Metrology personnel
• Strong mechanical inspection and manufacturing background within machining, stamping, or precision manufacturing environments
• Ability to read and interpret engineering drawings, GD&T, and specifications
• Strong leadership, communication, and problem-solving skills

• Medical Device manufacturing experience strongly preferred
• Experience with Keyence Measurement Systems
• CMM / VMM programming experience
• Experience with Minitab statistical analysis software
• Knowledge of APQP, PPAP, FMEA, SPC, and Gage R&R methodologies
• Lean Manufacturing and Continuous Improvement experience
• ASQ Certifications (CQE, CQM, etc.) are a plus