Quality Assurance Manager

Quality Manager

Location: Greater Bridgeport Area, CT

Job Type: Direct Hire

Salary: Competitive – Based on Experience (Flexible for Top Candidates)

Position Overview

We are partnering with a confidential, growing precision manufacturing company serving the Medical Device industry to identify an experienced Quality Manager. This is a hands-on leadership role responsible for leading the Quality Assurance, Quality Control, and Metrology teams while ensuring compliance with regulated manufacturing standards and driving continuous improvement throughout the organization.

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

Responsibilities

• Lead and manage the Quality Department, including Quality Engineers, Quality Inspectors, and Metrology personnel.
• Oversee daily Quality Assurance and Quality Control activities throughout manufacturing.
• Maintain and improve the Quality Management System in compliance with ISO 9001:2015 and ISO 13485:2016.
• Lead internal, customer, supplier, and third-party audits.
• Drive CAPA investigations, root cause analysis, corrective actions, and preventive actions.
• Manage calibration systems, metrology labs, and inspection equipment.
• Support APQP, PPAP, PFMEA, Gage R&R, capability studies, and First Article Inspections.
• Oversee CMM and vision measurement inspection programming.
• Review and approve quality documentation including SOPs, control plans, validation documents, work instructions, and procedures.
• Partner closely with Engineering, Manufacturing, Operations, and Supply Chain to improve quality, productivity, and manufacturing performance.
• Support prototype inspections, validations, supplier qualifications, and supplier change activities.
• Analyze quality metrics and statistical data to identify trends and implement corrective actions.
• Serve as the primary quality contact for customer concerns, complaints, audits, and regulatory compliance.
• Train, mentor, and develop Quality team members while promoting a strong culture of quality.
• Drive Lean Manufacturing and continuous improvement initiatives across the facility.

Qualifications

• Bachelor's Degree in Engineering, Manufacturing, Quality, or related technical field preferred.
• 5 years of Quality Management or Senior Quality Engineering experience within Medical Device or other regulated manufacturing environments.
• Strong working knowledge of:
• ISO 9001:2015
• ISO 13485:2016
• CAPA
• Internal and external audits
• Root Cause Analysis
• Validation processes
• Calibration and Metrology
• Experience leading Quality Engineers, Inspectors, and Metrology personnel.
• Strong manufacturing background within machining, precision manufacturing, or other highly regulated manufacturing environments.
• Ability to read engineering drawings, blueprints, GD&T, and specifications.
• Excellent leadership, communication, organizational, and problem-solving skills.

Preferred Qualifications

• Medical Device manufacturing experience strongly preferred.
• Experience with CMM programming and vision measurement systems.
• Knowledge of Minitab or other statistical analysis software.
• Experience with APQP, PPAP, FMEA, SPC, and Gage R&R methodologies.
• Lean Manufacturing and Continuous Improvement experience.
• ASQ Certifications (CQE, CQM, or similar) are a plus.

Work Environment

This position is based in a fast-paced, highly regulated manufacturing environment where quality, compliance, precision, and continuous improvement are critical to success. The Quality Manager will balance strategic leadership with a hands-on presence on the manufacturing floor, working closely with cross-functional teams to support operational excellence.

About the Opportunity

Our client is a confidential, well-established precision manufacturer serving the Medical Device industry. The company offers a collaborative culture, modern manufacturing operations, excellent leadership, and long-term growth opportunities. Additional company information will be shared during the interview process with qualified candidates.

Benefits

• Competitive salary based on experience
• Comprehensive medical, dental, and vision insurance
• 401(k) with company match
• Paid vacation and holidays
• Career growth opportunities
• Stable, growing organization

Interested?

Apply today by submitting:

• Updated resume
• Desired salary
• Availability

Qualified candidates will be contacted confidentially by Top Prospect Group / HW Staffing Solutions.