Job Description
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.
#INDTPGSHELTON
Numbers & Facts
| Location | Stratford, CT |
| Industry | Staffing/Employment Agencies |
| Company Size | 20 to 49 employees |
| Year Founded | 2009 |
| Website | http://www.topprospectgroup.com/ |
About Company
Top Prospect Group founders and management team offer more than 75 years of combined experience in Information Technology, Creative & Marketing, and Finance & Accounting staffing and solutions. Our fundamental goal is to build successful relationships resulting in accurate job and prospect representations. We meet with those we work with face-to-face to garner a better understanding of candidate or client requirements. By leveraging our experience and market insight, we are able to provide a more consistent recruitment process. Motivated by a partnership philosophy, our staff possesses a deep understanding of how to forge mutually beneficial long-term relationships. We believe in what we do and continuously strive for excellence.
Skills
- Advanced Product Quality Planning (APQP)unmatched
- American Society for Quality (ASQ)unmatched
- Analysis Skillsunmatched
- Blueprintsunmatched
- Calibrationunmatched
- Capability Maturity Model (CMM)unmatched
- Certified Quality Engineer (CQE)unmatched
- Communication Skillsunmatched
- Continuous Improvementunmatched
- Corrective Actionunmatched
- Corrective and Preventative Action (CAPA) Systemsunmatched
- Cross-Functionalunmatched
- Documentationunmatched
- Engineeringunmatched
- Engineering Drawingunmatched
- External Auditunmatched
- Failure Mode and Effects Analysis (FMEA)unmatched
- Geometric Dimensioning and Tolerancingunmatched
- ISO (International Organization for Standardization)unmatched
- ISO 9001unmatched
- Internal Auditunmatched
- Laboratory Equipmentunmatched
- Leadershipunmatched
- Lean Manufacturingunmatched
- Machiningunmatched
- Maintain Complianceunmatched
- Manufacturingunmatched
- Manufacturing Operationsunmatched
- Medical Equipmentunmatched
- Mentoringunmatched
- Metrologyunmatched
- Minitabunmatched
- Operational Supportunmatched
- Organizational Development/Managementunmatched
- Problem Solving Skillsunmatched
- Process Failure Mode and Effects Analysis (PFMEA)unmatched
- Process Improvementunmatched
- Production Part Approval Process (PPAP)unmatched
- Productivity Managementunmatched
- Prototypingunmatched
- Quality Assuranceunmatched
- Quality Controlunmatched
- Quality Engineeringunmatched
- Quality Managementunmatched
- Quality Metricsunmatched
- Regulatory Complianceunmatched
- Root Cause Analysisunmatched
- Standard Operating Procedures (SOP)unmatched
- Statistical Analysis System (SAS)unmatched
- Statisticsunmatched
- Statistics Softwareunmatched
- Supply Chain Operationsunmatched
- Systems Administration/Managementunmatched
- Trend Analysisunmatched
- Validation Documentationunmatched
- Validation Planunmatched
- Vendor/Supplier Evaluationunmatched
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