Senior Quality & Regulatory Leader – Medical Devices

Seaway Plastics; Port Richey (FL); Vor Ort; USD 110.000 - 160.000; Vollzeit

Zusammenfassung

Seaway Plastics in Port Richey, FL is seeking a hands-on Quality & Regulatory Manager to lead quality excellence, regulatory compliance, and continuous improvement in medical device manufacturing. The role requires ISO 13485 experience and strong root cause analysis and CAPA skills, with injection molding expertise highly preferred.

The successful candidate will balance leadership with hands-on technical involvement, driving CAPA, PPAP, validations, and a culture of quality on the production

Qualifikationen

• 15 years manufacturing experience in a production environment.
• 7–10 years quality management experience, preferably in a senior role.
• 5–10 years plastic injection molding experience.
• Self-starter able to motivate others.
• Decisive leader who delegates when appropriate.
• Strong written and verbal communication skills.
• GMP/quality initiatives experience.
• Deep experience with QMS including ISO 13485 and ISO 9001.
• Ability to foster a team oriented environment.
• Excellent knowledge of injection molding processes.
• Experience implementing continuous improvement and lean techniques.
• Strategic thinker with statistical data analysis skills.
• Willingness to travel up to 20% with a valid driver's license.

Aufgaben

• Oversee, maintain and improve the QMS.
• Update QMS to comply with new ISO standards.
• Oversee internal audit programs per ISO 13485.
• Drive continuous improvement focusing on processes and QMS.
• Support and maintain ISO standards.
• Ensure product quality levels meet metrics and raise awareness.
• Interface with all departments to define customer requirements in the QMS.
• Oversee document control for customer requirements, QMS, ISO and regulatory needs.
• Manage QA with customers including PPAPs, validations, complaints, audits.
• Manage product inspection activities: FAI, PPAP, validation, in-process, final.
• Develop and manage quality KPIs.
• Support purchasing with supplier development and audits.
• Foster a culture recognizing contributions and improvement.
• Stay updated on QA trends and align with customer needs.
• Collaborate with leadership to set quality targets.
• Support engineering tasks: DOE, product testing, quotes for new projects.
• Project management and new product support as needed.

Kenntnisse

QMS management

Internal audits

CAPA management

ISO 13485

Continuous improvement

DoE

CP/CPK

Root cause analysis

Injection molding

Lean Six Sigma

Jobbeschreibung

Seaway Plastics in Port Richey, FL is seeking a hands-on Quality & Regulatory Manager to lead quality excellence, regulatory compliance, and continuous improvement in medical device manufacturing. The role requires ISO 13485 experience and strong root cause analysis and CAPA skills, with injection molding expertise highly preferred.

The successful candidate will balance leadership with hands-on technical involvement, driving CAPA, PPAP, validations, and a culture of quality on the production