Data Control Supervisor jobs in Hialeah, FL

1. Job Title

1.1. Quality Control Supervisor

2. Location

2.1. Miami Lakes, FL

3. Functional Area

3.1. Quality Assurance

4. Duties and Responsibilities

4.1. Schedule and review incoming, in-process, first article, and final inspections of mechanical and electro-mechanical medical devices and components using optical and mechanical inspection tools and equipment

4.2. Conduct paperwork review of Receiving Inspections, Device History Records (DHRs)/Travelers.

4.3. Aid in the initiation, investigation, and documentation of NCMs, Corrective Actions, Preventative Actions

4.4. Aid in the creation and revising of documentation such as SOP’s, Inspection Plans, Verifications, Work Instructions, etc.

4.5. Plan, coordinate, and direct the equipment management system to ensure effective maintenance, calibration, and qualification program of equipment and tools

4.6. Perform or coordinate conductance of maintenance, calibration, and qualification activities of equipment

4.7. Identifying, segregating, and removing from use out-of-calibration equipment or equipment out of service or repair including notification of equipment location.

4.8. Review daily environmental monitoring of critical equipment such as the DI water system and cleanroom

4.9. Plan, coordinate, maintain supplier management program by ensuring supplier forms are completed, filed, and IQMS supplier information is up to date.

5. Reports To

5.1. Quality and Regulatory Affairs Manager

6. Supervisory Responsibilities

6.1. Yes

7. Qualifications

7.1. Education

7.1.1. High school diploma or equivalent, Technical/associates degree

7.2. Required Experience

7.2.1. Experience in Quality or Manufacturing for a Medical Device Manufacturer preferred

7.2.2. GMP experience preferred

7.2.3. ASQ CMI or CQT preferred

7.2.4. Familiarity with FDA QSR, ISO 13485, ANSI Z 1.4, ANSI Z1.9 preferred

8. Language Skills

8.1. Fluent in English

8.2. Must have excellent English written and verbal skills

8.3. Must be able to read and interpret mechanical drawings

8.4. Must be able collect and document inspection data

8.5. Attention to detail and multi-tasking skills are a must

8.6. Proficiency with Microsoft Suite necessary

9. Physical Demands

9.1. Frequently required to sit

9.2. Occasionally required to move about

Job Type: Full-time

Pay: $20.00 per hour

Expected hours: 40 per week

Benefits:

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

Schedule:

• 8 hour shift
• Monday to Friday

Work setting:

• In-person

Experience:

• Quality control: 1 year (Required)

Work Location: In person