Company: MPS Medical, Inc.
Posted on: February 19, 2021
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
In this role the Quality Engineer acts as departmental manager to
works with the Quality Assurance department and personnel on the
implementation of the Quality Assurance System. Assist MPS to
verify Quality Products, on time and within budget.
- Serve as the quality representative during any product or
process investigation. Lead investigations including root cause
analysis and health risk assessment of the identified product or
- Prepare and execute validations, technical studies, test method
validations and other studies / reports as required. This includes
preparation of protocols, establishment of test methodology and
acceptance criteria, training personnel, execution, data analysis,
investigation, and writing final reports.
- Initiate and lead project teams on Corrective Action/Preventive
Action (CAPA) projects. This includes, but is not limited to,
performing risk analysis, root cause analysis; developing a
corrective action plan, implementing the plan, and submitting a
summary report for project closure.
- Assist Complaint Handling Department with technical/engineering
support regarding customer complaints and product returns.
Investigation may involve reviewing manufacturing batch records,
vendor component records, MRB records, etc. to determine root cause
of product failure.
- Prepare and report appropriate metrics to executive
- Interface with external auditors (Notified Body, FDA, etc.)
during audits at the Monrovia site; participate in the preparation
and completion of corrective action plans as needed.
- Minimum two year's experience or advanced degree with one year
of experience in quality engineering in the medical device or
pharmaceutical industries, including the practical application of
FDA Quality System Regulation and ISO 13485 or equivalent. General
knowledge of manufacturing processes such as assembly, packaging,
and sterilization required.
- Excellent understanding of quality system regulations
applicable to the design, manufacture and distribution of medical
devices or drugs.
- Solid understanding of investigation techniques including
design of experiments and root cause analysis.
- Demonstrated understanding and application of Quality System
Auditing and Analysis
- Solid grasp of basic statistical techniques with basic
understanding of advanced techniques in data analysis.
- Excellent project management, organization, writing and
presentation skills required.
- Demonstrated expert knowledge of Windows-based software,
including Word, Excel, Access, Project, and Power Point.
PHYSICAL DEMANDS -Reasonable accommodations may be made to enable
individuals with disabilities to perform the following essential
- Physically able to sit, stand and walk for extended periods of
- Able to move about on foot; walk up and down stairs repeatedly
- Clarity of vision at 20 inches or more; able to view a computer
monitor for extended periods of time.
Keywords: MPS Medical, Inc., Fullerton , Quality Engineer, Accounting, Auditing , Brea, California
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