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 nonconformities.
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 corrective action.
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.
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 13485:2016
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 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.