Quality Control Manager - Medical Device
Location: Fort Myers, FL
Working Situation: Onsite
Level: Senior Level
Our client is a global medical device company who is the industry leader of new product development. Our innovative company is actively searching for a new Quality Control Manager for our manufacturing site. The Quality Control Manager would be responsible for all manufacturing Quality Control activities to ensure all products meet all safety and efficacy requirements.
The Quality Control Manager will be responsible for:
- Leads and mentors the Quality Control team to enhance personnel performance and refine product quality inspection methodologies, fostering a culture of continuous improvement.
- Proactively assesses and enhances quality control inspection techniques and operational efficiency.
- Coordinates the assessment and approval process of both internal and externally sourced Non-Conformance Reports (NCRs), Corrective and Preventive Actions (CAPAs), Deviations, and other inputs to the Quality System.
- Ensures timely identification, documentation, and resolution of nonconforming materials across all stages of product acceptance.
- Develops and maintains robust quality control inspection plans, tests, and methods, incorporating statistical methodologies where applicable.
- Facilitates comprehensive employee training initiatives to ensure competency.
- Tracks and reports on departmental process efficiency metrics and benchmarks.
- Reviews and approves pertinent Quality System documentation, ensuring compliance.
- Fosters effective cross-departmental communication and collaboration to optimize quality system execution.
The Quality Control Manager will have the following qualifications:
- Bachelor's degree in Science, Engineering, or related field
- 5+ years of related experience in a Medical Device manufacturing environment in Quality Systems, Quality Control, and/or Quality Engineering
- 3+ years of leadership experience
- Familiarity with ISO 13485, FDA, and EN regulations
If you are interested in this Quality Control Manager opportunity, apply now!
