Quality Assurance Manager
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 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
- Support Site Operations, Quality, and R&D teams by
addressing issues and opportunities that might arise. The Quality
Manager will serve as the quality representative during any product
or process investigation including root cause analysis and health
risk assessment of the identified product or process
- 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 non-conformance
investigations regarding component failures, finished goods
failures, and product returns. This includes but is not limited to
performing risk analysis, determining root cause and recommending
- Conduct internal audits and supplier audits. This includes
preparation of audit plans, audit reports, and verifying corrective
actions have been completed and are effective. Act as Management
representative for FDA and ISO audits.
- Lead assigned 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 and conduct effectively checks (EC).
- Manage customer complaints and product returns including
investigations to determine root cause is product related as well
as corrective actions.
- Ensure Regulatory Compliance by managing and update internal
procedures with new standard updates. Continuously work to align
procedures with current practices.
- Generate and update work instructions and SOP's to standardize
documentation processes. Qualifications
- 6-10 years of experience working in a medical Device
manufacturing quality role some in management.
- Proficient in Risk Management - ISO 14971:2012 and FDA QSR, ISO
- ASQ certification a plus.
- Knowledge of European device requirements a plus.
- Hands-on experience with development of quality plans, design
control documents, management of DMR and DHR's, problem solving,
statistical methods, test protocols, technical reports, risk
analysis and data analysis.
- Thorough knowledge of FDA and ISO standards and managing
associated quality systems.
- Experience working with interdisciplinary including management,
marketing, engineers, and vendors.
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 Assurance Manager, Executive , Brea, California
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