Quality Manager

Quality Manager at Top Prospect Group Quality Manager at Top Prospect Group in Trumbull, Connecticut Posted in about 22 hours ago.

Type:

full-time

Job Description:

Job Title:

Quality Manager Location:

Trumbull CT Pay Rate:

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

Type:

Direct Hire Schedule:

1st Shift Overview 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. Key Responsibilities 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 Qualifications 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 Root Cause Analysis 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 Preferred Qualifications 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