Hands-On Quality & Regulatory Lead (ISO 13485)

MME group Inc.; Port Richey (FL); On-site; USD 95,000 - 150,000; Full time

Job summary

Seaway Plastics seeks a hands-on Quality & Regulatory Manager to lead from the front in a medical-device manufacturing setting. The ideal candidate has ISO 13485 experience, strong problem-solving and statistical skills, and the ability to drive the team to tangible quality improvements.

Responsibilities include owning the QMS, leading registrar/FDA/customer audits, and managing CAPA, NCR/MRB, and supplier quality.

Qualifications

• Bachelor’s degree in engineering or related technical discipline required.
• Six Sigma Green Belt or higher preferred; experience with DMAIC/DOE is a plus.
• Strong working knowledge of ISO 13485 and 21 CFR Part 820 (QMSR).
• Experience with CAPA, NCR/MRB, complaint handling, and change control.

Responsibilities

• Own, maintain, and continuously improve the site QMS to ISO 13485:2016 and 21 CFR Part 820 (QMSR).
• Lead audits (registrar, FDA, customer) and close findings timely and effectively.
• Oversee CAPA, NCR/MRB, complaint handling, change control, document control, training, and calibration systems.
• Apply risk-based decision making to PFMEAs, control plans, and dispositions; prepare management review inputs on QMS effectiveness.

Skills

Problem solving

Leadership

Statistical analysis

Regulatory knowledge

Education

Bachelor’s degree in engineering or related technical discipline

ASQ/CQE/CMQ certifications

Tools

Minitab

GD&T interpretation

Job description

Seaway Plastics seeks a hands-on Quality & Regulatory Manager to lead from the front in a medical-device manufacturing setting. The ideal candidate has ISO 13485 experience, strong problem-solving and statistical skills, and the ability to drive the team to tangible quality improvements.

Responsibilities include owning the QMS, leading registrar/FDA/customer audits, and managing CAPA, NCR/MRB, and supplier quality.