Classification: Non- Exempt

Overtime Required: Yes

DESCRIPTION
The Quality Specialist is responsible for day-to-day QMS (quality management system) activities. This role reports to the Director of Quality and assists, organizes, and implements processes required for successful operation and development of Med-Lab’s Quality Department. This role also organizes, supports, and develops processes for the company’s Environmental Health and Safety (EHS), Document Control, and Quality Monitoring and Measurement.

ESSENTIAL DUTIES: QMS (Quality Manual System) Ambassador and champion- collaborate well with other departments to drive business objectives.

• Follow the CPAR (Corrective Preventative Action Request) administration process in handling of SOPs and other quality documentation.
• Assist with the development of quarterly reports on Key Performance Indicators (KPI’s).
• Assist with the creation and implementation of quality related training into LMS (learning management system).
• Assist Quality Department with:
• a quality management execution that is aligned with the overall strategy with the company.
• management reviews and Strategic Planning sessions
• ISO certification and recertification
• Siemens Audit certification process and any other quality audits.
• documentation of Management Review and Strategic Planning in the QMS
• ensuring clear, concise, and accurate policies, procedures, instruction, forms, and objectives are provided & maintained.
• Risk Management processes, documentation, and coordination
• processes for monitoring, auditing, and measuring quality
• any other quality-oriented processes and initiatives

SAFETY AND EHS MANAGEMENT Participate in and document safety committee meetings that will implement and convey to the company any changes agreed.

• Ensure safety rules are properly documented and strategically posted.
• Participate in a yearly safety audit and ensure a Safety Audit Report is properly documented and stored in the Quality Management System
• Monitor and establish a calibration process for essential tools

DOCUMENT CONTROL Ensure that information is effectively selected, managed, and used to support key processes and activities and improve overall performance.

• Ensure documents are adequate, comprehensive, clear, concise, and accurate
• Provides unique document numbers and revision updates.
• Describes changes made to a document when submitting for approval.
• Controls distribution of documents and configures who can view the documents by company, role, and security clearance level.
• Maintain obsolete documents and revisions in a separate location
• Review documentation every three years, or more frequently if necessary.
• Ensures all documents are backed up

SKILLS AND ABILITIES

• Fosters and provides examples of Trust
• Customer service focus (internal & external)
• Integrity
• Written comprehension
• Deductive reasoning
• Written and Oral Communication skills
• Attention to detail
• Active listening
• Ability to document and record information
• Problem solving skills
• Processing information
• Computer skills
• Safe driving
• Ability to manage teams

QUALIFICATIONS
A high school diploma, Associates degree preferred

1-3 years of related Quality experience required with at least 1 year as a quality admin or similar role highly preferred.

Experience in Healthcare and CAPA processing preferred.

Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without notice.

Job Type: Full-time

Pay: $40,837.14 - $60,000.00 per year

Benefits:

• 401(k)
• 401(k) matching
• Dental insurance
• Flexible schedule
• Health insurance
• Life insurance
• Paid time off
• Tuition reimbursement
• Vision insurance

Schedule:

• 8 hour shift
• Monday to Friday

Supplemental pay types:

• Bonus pay

Ability to commute/relocate:

• Miami, FL 33126: Reliably commute or planning to relocate before starting work (Required)

Work Location: Hybrid remote in Miami, FL 33126

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