QMS Specialist: ISO 13485 & FDA QSR

Paylocity; Lakeland (FL); On-site; USD 80,000 - 110,000; Full time

Benefits offered by this job

Health, dental and vision insurance

Unlimited discretionary time off

401K matching

Flexible schedule

Job summary

Molekule is seeking a QMS Specialist to implement and audit quality systems ensuring ISO 13485 and FDA QSR compliance for products and facilities. This role manages the electronic QMS (Greenlight Guru), drives CAPAs, and collaborates with audits, design controls, and process improvements in a manufacturing environment.

Ideal candidates have a science degree, 3+ years of QMS experience, and strong communication skills to support regulatory readiness and product quality initiatives.

Qualifications

• Bachelor's degree in science or related field.
• 3+ years’ QMS experience; Class II medical devices preferred.
• Expertise in FDA regulations and interpretation.
• Proficient with Microsoft Excel, PowerPoint and electronic QMS systems.
• Greenlight Guru experience is a plus.
• Strong analytical capabilities.
• Excellent communication and clear writing.

Responsibilities

• Own the electronic QMS tool (Greenlight Guru) to meet ISO13485 and FDA QSR.
• Provide compliance direction, investigate complaints and verify corrections.
• Maintain product quality files including design history and technical files.
• Track and close CAPAs, Nonconformances and Post Market Surveillance.
• Assist with external audits by customers and FDA.
• Assist with quality inspection of products and components.
• Lead or facilitate root cause analyses as needed.
• Gather data for regulatory, productivity and management review indicators.
• Conduct internal QMS audits and implement regulatory changes.
• Support changes to design specifications and change control processes.
• Support process control improvements and develop procedures.
• Deliver employee communication and training on QMS policies.

Skills

QMS experience

FDA regulations

MS Excel

PowerPoint

Analytical skills

Communication

Quality system audits

Education

Bachelor's degree in science or related field

Tools

Greenlight Guru

Job description

Molekule is seeking a QMS Specialist to implement and audit quality systems ensuring ISO 13485 and FDA QSR compliance for products and facilities. This role manages the electronic QMS (Greenlight Guru), drives CAPAs, and collaborates with audits, design controls, and process improvements in a manufacturing environment.

Ideal candidates have a science degree, 3+ years of QMS experience, and strong communication skills to support regulatory readiness and product quality initiatives.