Quality Manager

Location: Brooksville, Florida
Work Arrangement: Onsite
Employment Type: Direct Hire
Salary Range: $85,000 – $100,000 annually, depending on experience

Position Overview

We are seeking an experienced Engineering Quality Manager to support new product development and ongoing manufacturing operations within a regulated medical-device environment.

This position will work closely with Engineering, Production, and Operations to ensure products, manufacturing processes, and quality systems meet applicable regulatory and industry requirements, including ISO 13485, ISO 9001, and 21 CFR Part 820.

The Engineering Quality Manager will combine hands-on quality engineering responsibilities with continuous-improvement leadership. Key areas of focus include process verification, process validation, statistical process control, root-cause analysis, design transfer, process capability, and sustainable quality controls.

The ideal candidate is self-motivated, detail-oriented, and capable of working independently while building strong partnerships across multiple departments.

Key Responsibilities

• Partner with Engineering on new product development projects to ensure quality requirements are incorporated throughout the design and development lifecycle.
  

• Develop and maintain new-product quality documentation, including process-flow diagrams, PFMEAs, control plans, inspection requirements, and validation protocols.
  

• Perform and document process verifications, first-article inspections, statistical process control studies, and process-capability evaluations.
  

• Participate in design-transfer and process-validation activities to ensure production processes consistently meet product and regulatory requirements.
  

• Analyze quality data, manufacturing trends, SPC results, and process-capability metrics to identify opportunities for improvement.
  

• Lead or support root-cause investigations, nonconformance reviews, corrective and preventive actions, and risk-management activities.
  

• Maintain and update manufacturing methods, equipment records, tooling documentation, and engineering-change documentation.
  

• Create and revise standard operating procedures, work instructions, inspection procedures, and quality-control documentation.
  

• Identify opportunities to improve product quality, process performance, operational efficiency, and regulatory compliance.
  

• Recommend and implement corrective actions, preventive measures, and improved process controls.
  

• Train and mentor employees on quality-control principles, process capability, documentation requirements, and regulatory compliance.
  

• Support internal audits, external audits, supplier evaluations, and management-review activities.
  

• Ensure quality records and controlled documents are accurate, complete, current, and properly maintained.
  

• Promote a proactive quality culture focused on continuous improvement, accountability, compliance, and patient safety.

Required Qualifications

• Experience in Quality Engineering, Quality Assurance, Manufacturing Quality, or a related function within medical-device manufacturing or another highly regulated industry.
  

• Strong working knowledge of ISO 13485, ISO 9001, 21 CFR Part 820, and Quality Management System requirements.
  

• Hands-on experience with statistical process control, process verification, process validation, root-cause analysis, and corrective and preventive action systems.
  

• Experience developing and maintaining PFMEAs, control plans, process-flow diagrams, inspection requirements, and validation protocols.
  

• Demonstrated ability to lead cross-functional teams and manage quality-improvement initiatives.
  

• Strong analytical, problem-solving, and decision-making skills.
  

• Excellent written and verbal communication skills.
  

• Ability to work independently, prioritize multiple assignments, and maintain productivity with limited supervision.
  

• Strong attention to detail and organizational discipline when managing documentation, records, and quality data.
  

• Sound judgment and the ability to balance regulatory requirements with operational efficiency.
  

• Commitment to continuous improvement and building a strong quality culture.

Preferred Qualifications

• Quality leadership experience within a regulated manufacturing environment.
  

• Experience supporting medical-device design transfer and new-product introduction.
  

• Experience with supplier quality, internal auditing, and regulatory inspections.
  

• Familiarity with risk-management tools and process-capability metrics, including Cp and Cpk.
  

• Experience training or mentoring engineering, manufacturing, or quality personnel.

Working Conditions and Physical Requirements

• Full-time, onsite position in Brooksville, Florida.
  

• Ability to occasionally lift or move materials weighing up to 20 pounds.
  

• Ability to stand, sit, or work at a computer for extended periods.
  

• Ability to move throughout manufacturing, inspection, production, and office areas.
  

• Occasional exposure to manufacturing noise, equipment, chemicals, or materials requiring appropriate personal protective equipment.
  

• Ability to safely handle controlled or potentially hazardous materials in accordance with established safety procedures.

Regulatory Responsibility

The Engineering Quality Manager is responsible for supporting compliance with all applicable Quality Management System and regulatory requirements.

This position must ensure that quality documents and records are properly controlled, maintained, and retained in accordance with established procedures and applicable standards. Failure to follow established procedures or maintain accurate records may affect product quality, regulatory compliance, and patient safety.

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