Full Job Description
- Oversees the assembly and testing of medical devices, particularly blood cell counters. Supervises staff. Ensures that quality control standards are followed.
- Recruits, interviews, hires, trains, coaches, evaluates and disciplines employees as required; supervises and works alongside employees, as required.
- Manages resource and capacity plans in order to meet the customer’s requirements.
- Schedules and chairs weekly In-process Rejects meetings to discuss disposition of materials for process improvement.
- Assists in the proper disposition of Non-Conforming product.
- Initiates and implements Corrective Action/Preventive Actions for internal and external components and processes to promote continuous improvement efforts.
- Ensures correct implementation of Document Change Notices and contents of Device History Records.
- Ensures schedules and quality of product is maintained.
- Produces and presents metrics for various processes and systems to foster continuous improvement.
- Schedules appropriate overtime hours to meet production schedules.
- Provides and maintains employee training and documentation.
- Coordinates real time with engineering/technicians for resolution to process, equipment and resource issues.
- Manages elements of the departmental budget.
- Performs inspections as necessary to assist staff with backlog and daily workloads.
- Resolves work problems.
- Recommends changes to improved product flow, quality and productivity.
- Performs other duties as requested and/or required.
Qualifications and Educational Requirements
- BA/BS degree preferred.
- Knowledge of GMP and ISO-9000 a must.
- Two or more years of prior supervisory experience in a manufacturing environment with exposure to an FDA-regulated environment preferred.
- Must be familiar with QC and calibration systems.
- Must be able to read and interpret engineered drawings of Electro-Mechanical components.
- Prior experience with Non-Conforming Material processes required.
- Ability to perform mechanical and electrical inspections utilizing various measurement techniques and industry standards required.
- Strong written and verbal communication skills.
- Ability to perform multiple tasks.
- Computer proficiency with Microsoft Office Suite.
- Excellent interpersonal skills required.
- Proficient in planning, organizing and prioritizing.
Job Type: Full-time
Pay: $50,000.00 – $58,000.00 per year
- 401(k) matching
- Dental insurance
- Employee discount
- Flexible spending account
- Health insurance
- Life insurance
- Paid time off
- Vision insurance
- 8 hour shift
- Monday to Friday
Ability to commute/relocate:
- Deerfield Beach, FL 33442: Reliably commute or planning to relocate before starting work (Required)
Work Location: One location