Quality Assurance Manager
Jacksonville, FL 32246
Agility Staffing is currently hiring a Quality Assurance Manager to become an integral part of our team. Our Client is the leading provider in medical and surgical supplies. The hours are Monday through Friday 9: 00am to 6: 00pm. The salary is $100, 000- $105, 000/yr. DOE. The company offers Medical, Dental and Vision as well as 401-K. In addition, employees receive 16 vacation days and 10 paid holidays.
The Quality Assurance Manager will be responsible for management and direction of all Quality Assurance and Regulatory Affairs related activities at the medical device manufacturing facility. The Quality Head will have direct accountability to the President for all Quality and Regulatory related deliverables. The Manager is also the Official Correspondent to the FDA for all Class I and Class II Medical Devices as both contract manufacturer and legal manufacturer, as well as Initial Importer of Medical Devices used as raw materials in the manufacturing process.
Additional Responsibilities include:
- Lead/guide all Quality Systems, Quality Engineering, and Regulatory Affairs activities
- Directly or indirectly plan, write, coordinate, execute, summarize, review, IQ, PQ, OQ, validation protocols
- Responsible for the development of quality programs and fully accountable for adherence to timelines
- Responsible for preparation of internal monthly quality reporting
- Manage/develop departmental budget
- Recruit, hire and train direct reports
Requirements to be considered:
- Must have thorough understanding of current Good Manufacturing Practices, Quality Management Systems, U.S. FDA regulatory requirements, supplier quality management, process and equipment qualification and validation principles and in a U.S. Market medical device regulated environment.
- Bachelor of Science in a Science, Technology, Engineering or other closely related discipline
- ASQ certified in one or more of Quality Engineer / Auditor / Manager preferred
- 5 years of progressive management experience in medical device QA
- ISO 13485 and 21 CFR Part 820 expertise is absolutely required
- Proficient user of Microsoft Office applications