Quality Systems Specialist II – Hybrid/ Flexible Hours

Kls Martin Lp; Jacksonville (FL); Hybrid; USD 75,000 - 110,000; Full time

Job summary

KLS Martin LP is seeking a Quality Management System Specialist II to advance the QMS for medical devices. You will independently lead complex QMS processes, assess risks, and support audits across regulatory requirements, contributing to compliant improvements and training of team members.

The role requires flexibility to support regulatory compliance and a mix of onsite and local remote work within Jacksonville, FL. Strong knowledge of ISO 13485 and FDA guidance is essential.

Qualifications

• Knowledge of device regulations ISO 13485, FDA, SOR 98 282.
• 4 year degree plus 3 to 5 years of work experience in a regulated industry.
• 5 years of experience in regulated industry.
• Proficient user of Microsoft Office applications, with intermediate knowledge of MS Excel.

Responsibilities

• Support the administration, maintenance, and continual improvement of the Quality Management System (QMS) at KLS.
• Lead implementation and monitoring of assigned QMS processes, procedures, quality plans, and improvement initiatives.
• Independently manage complex or multiple assigned QMS processes, records, projects, and action items.
• Support recalls and advisory notices, including coordination of assigned activities.
• Plan, conduct, document, and follow up on risk-based process audits, and lead or support internal and external audits.
• Coordinate audit evidence and capture accurate and timely minutes during audits.
• Draft, review, and approve quality documents and procedures.
• Evaluate, document and communicate QMS impacts and recommend appropriate actions or controls.

Skills

Regulatory knowledge ISO 13485 FDA SOR

MS Excel

Microsoft Office Suite

Quality systems understanding

Education

Bachelor's degree

Tools

SharePoint

Job description

KLS Martin LP is seeking a Quality Management System Specialist II to advance the QMS for medical devices. You will independently lead complex QMS processes, assess risks, and support audits across regulatory requirements, contributing to compliant improvements and training of team members.

The role requires flexibility to support regulatory compliance and a mix of onsite and local remote work within Jacksonville, FL. Strong knowledge of ISO 13485 and FDA guidance is essential.