Manages and supports the implementation and maintenance of the company's Quality Systems. Coordinates with the DQA and all departments and related entities to ensure that all Quality Systems are functioning effectively and timely. Proactively implement regulatory changes and requirements. Understands the entire scope of the Quality Systems to manage the compliance, linkages and interactions between processes and departments. Supports senior management in communicating and engaging company employees in the importance of utilizing the Quality System for the success of the company.
Qualifications
Education - Bachelors or Masters degree in an organizational-based discipline is highly
preferred
Previous Work Experience - 5 years experience in a Medical Device related Quality
Assurance (QA) environment is highly preferred. Exposure to different companies'
quality systems is desired. (MDR, ISO 13485, ISO 9001, PPE, and FDA)
Learned Skills - Familiar with standard and GMP manufacturing operations and quality
systems is desired.
Strong written and verbal communications skills, as well as strong interpersonal skills are required.
Primary Responsibilities
1. Supports the DQA in establishing the QA system in the company. Periodically reports directly to the CEO on the state of the Quality Program.
2. Works with the DQA and CEO in communicating the benefits of the company's Quality Systems to employees.
3. Participates with the senior management team in the development and implementation of the company's strategic plans. Specifically, the Quality Manager supports the DQA in ensuring the QA system is operating effectively and is in compliance with FDA and ISO requirements.
5. Assists in ensuring that the company receives and maintains FDA and ISO approvals for all products in the company's facility or in other facilities if contract manufacturing is required.
6. Manages all records and documents within the Quality System for accuracy and completeness.
7. Assists departments and entities with implementation of new processes and ensures that quality processes are appropriately considered and incorporated, as appropriate.
8. Manages reoccurring quality requirements and reporting
9. Performs internal QA audits of selected departments on a regular basis.
10. Provides periodic training or coordinates the in-house training of associates regarding quality and safety.
11. Pursues and monitors the regulatory marketplace for new regulatory requirements.
12. Performs other duties as assigned.
Knowledge and Skill Requirements
1. Experience in quality assurance programs and processes.
2. Knowledge of radiation concepts and radiation safety is highly desirable.
3. Experience in achieving objectives with limited resources and a commitment to quality.
Adherence to the Quality System
The associate agrees to participate actively in the Quality System and perform all job tasks and responsibilities according to defined processes, procedures, work instructions, etc as addressed in the WIT Quality System as an expected condition of employment at WIT, Inc.
Health & Safety Requirements
Must wear head covering and standard manufacturing apparel in the manufacturing area as stipulated by the company.
Working Conditions
Work may require occasional weekend and/or evening work and travel.