Quality Systems Lead: Compliance & Process Excellence

Evergen; Florida; On-site; USD 70,000 - 80,000; Full time

Benefits offered by this job

Paid Time Off (PTO)

401(k) with company match

Holiday pay

Medical, dental, and vision insurance

Short-term and long-term disability

Job summary

Evergen, located in Alachua, FL, is seeking a Quality Systems Supervisor to oversee critical quality programs and ensure regulatory compliance. The role involves leading a team, coordinating audits, and driving process improvements within a robust quality management framework.

The ideal candidate will have 3+ years in QA/regulatory fields, 2+ years in leadership, and an Associate’s degree. On-site position with comprehensive benefits and a fixed salary range of $70,000–$80,000 per year, plus a

Qualifications

• Associate’s degree required.
• 3+ years of quality assurance, systems, regulatory affairs, or related experience in a regulated industry such as tissue, medical device, or pharmaceutical.
• 2+ years of leadership experience.
• Alternative combinations of education and experience may be considered.

Responsibilities

• Oversees and executes functions within critical Quality Systems programs to ensure compliance with applicable regulations, standards and company objectives.
• Supports quality system compliance with internal and external regulatory requirements and maintains awareness of the regulatory landscape.
• Collects, analyzes, and reports data to demonstrate conformity and maintains effectiveness of the quality management system.
• Supports process improvement initiatives that impact quality systems and collaborates with cross-functional stakeholders to ensure compliance of processes and procedures.
• Supports third-party audits, including Notified Body inspections, through planning, execution, closeout, and follow-up with high customer service.
• Acts as a subject matter expert during audits for responsible processes.
• Reviews and approves quality system documentation for accuracy and consistency.
• Delivers training on responsible processes.
• Coordinates and leads daily team activities and performance management, hiring, scheduling, corrective actions, and other employee relations issues.
• Maintains records management system including secure storage, retrieval, retention, and destruction.

Skills

Verbal and written communication

Microsoft Office

QMS software

Problem solving

Data analysis

Records management

Education

Associate’s Degree

Job description

Evergen, located in Alachua, FL, is seeking a Quality Systems Supervisor to oversee critical quality programs and ensure regulatory compliance. The role involves leading a team, coordinating audits, and driving process improvements within a robust quality management framework.

The ideal candidate will have 3+ years in QA/regulatory fields, 2+ years in leadership, and an Associate’s degree. On-site position with comprehensive benefits and a fixed salary range of $70,000–$80,000 per year, plus a