Quality Compliance and Regulatory Affairs Manager
- 785 Challenger St, Brea, CA 92821, USA
On December 31st, 2020 Innova Medical, Inc. acquired MPS Medical to expand its U.S production of COVID-19 antigen test kits, producing over 4 million SARS-CoV-2 Antigen Rapid Qualitative Tests per day. Currently, Innova Medical Group, Inc. is the world’s largest manufacturer of rapid antigen test kits and leader in COVID-19 testing solutions arena.
Innova Medical Group, Inc. achieves to deliver better global health outcomes with its deep expertise in testing and unique offerings in diagnostic medical devices and services that help tackle some of the world’s most challenging healthcare problems. Alongside of COVID-19 solutions, Innova specializes in innovative screening, testing and diagnostics for cancer, heart disease, arterial calcification, stroke, and virus detection focused on infectious disease.
In this role coordinates activities related to production, personnel handling, quality assurance, material requesting and internal customer service in product manufacturing. This includes activities area assigned in the clean room and packaging area.
- Responsible for ensuring that processes needed for the quality management system are documented.
- Responsible for reporting to top management on the effectiveness of the quality management system and any need for improvement.
- Responsible for ensuring the promotion of awareness of applicable regulatory requirements and quality management system requirements throughout the organization.
- Responsible for hiring, training, evaluating and assigning/delegating project/duties to the quality staff.
- Responsible for implementing all elements of ISO and FDA requirements.
- Management representative during external agency audits such as FDA and ISO.
- Responsible for ensuring all management review meetings are conduct per schedule and meeting minutes and agenda items are documented per approved procedures.
- Responsible for implementation and reviews the effectiveness of the corrective and preventive action program.
- Responsible for schedule, perform and monitor internal quality audits.
- Responsible for implementation and reviews for all customer complaints and the associated system to make certain all complaints are handled per approved procedures.
- Responsible for implementation of documentation control system.
- Responsible for implementation of equipment calibration and preventive maintenance programs.
- Responsible for implementation and reviews the disposition on non-conformances.
- Responsible for maintaining current with external regulatory requirements.
- Responsible for Quality and Regulatory aspects of manufacturing.
- Supervise the Quality Department and personnel.
- To perform this job successfully, an individual must be able to perform each essential duty satisfactorily.
- The requirements listed below are representative of the knowledge, skill, and/or ability required.
- BS degree or equivalent experience.
- Minimum of 5 years QA experience with Medical Device Manufacturing.
- Thorough understanding of the FDA’s QSR, ISO 13485 and applicable ISO standards.
- Requires the ability to communicate effectively, written and verbal as well as good people skills.
PHYSICAL DEMANDS –Reasonable accommodations may be made to enable individuals with disabilities to perform the following essential physical demands:
- Physically able to sit, stand and walk for extended periods of time.
- Able to move about on foot; walk up and down stairs repeatedly as needed.
- Clarity of vision at 20 inches or more; able to view a computer monitor for extended periods of time.