Quality Manager

Location: On-site in Brooksville, FL and Tampa, FL

A leading innovator in precision electromechanical systems is seeking a Quality Manager to elevate product quality and operational excellence across its design and manufacturing teams. This position plays a crucial role in bridging engineering and production to ensure all products comply with stringent regulatory and quality standards. As the organization continues to expand, this role offers an exceptional opportunity to take the lead in shaping a proactive and future‑forward quality culture.

• Drive quality assurance for New Product Introductions (NPI), collaborating with engineering teams to embed quality from concept through production.
• Lead the development of key quality documentation, including Process Flow Diagrams, PFMEAs, Control Plans, and Validation Protocols (IQ/OQ/PQ).
• Oversee process verification, first article inspections, and statistical studies (SPC/CPK) to establish and maintain robust process capabilities.
• Support design transfer and validation to ensure manufacturing readiness aligns with compliance standards and product specifications.
• Analyze manufacturing data and process trends to initiate corrective and preventive actions (CAPA) and continuous improvement.
• Guide nonconformance investigations and risk assessments using structured problem‑solving tools such as root cause analysis and 5 Whys.
• Maintain and improve documentation including work instructions, manufacturing methods, equipment records, and change notices.
• Lead SOP development and updates in alignment with evolving industry best practices and regulatory guidelines.
• Train cross‑functional teams in regulatory standards, process control, and quality systems to build a strong internal quality competency.
• Actively contribute to audit readiness, supplier quality assessments, and internal management reviews.

• Proven experience in Quality Assurance or Quality Engineering within the medical device or regulated manufacturing industries.
• Strong command of ISO 13485, ISO 9001, and FDA 21 CFR 820 standards.
• Proficiency in statistical process control, corrective action systems, and process validation methodologies.
• Skilled in producing and managing PFMEAs, Control Plans, and equipment validation documentation.
• Exceptional communication skills with the ability to lead cross‑functional initiatives and implement process improvements independently.

• Advanced knowledge of quality tools and methodologies (e.g., Fishbone Diagrams, DMAIC).
• Confident in navigating complex regulatory environments while promoting practical, efficient quality solutions.
• Demonstrated leadership in training and mentoring teams on compliance and quality strategy.
• Resourceful, self‑driven professional with the ability to manage responsibilities with minimal oversight.
• Light physical requirements, including lifting up to 20 lbs and extended periods of sitting or standing.
• Regular interaction with engineering, manufacturing, and leadership teams in a hands‑on production setting.
• Occasional exposure to lab and manufacturing floor environments, requiring standard PPE.