Michael Taber Email & Phone Number

Brea, California, United States

Responsible for the maintenance and implementation of Quality System procedures necessary for the efficient operation of the local quality system, ensuring their compliance with regulatory and corporate requirements as well as industry best practices.Acting as Deputy Management Representative for the Brea site. Taking the lead Role in external audits. Ensure site is in a state of audit-readiness.Facilitating Quality System Management Reviews (QSMR) for the site. Ensuring timely… Show more Responsible for the maintenance and implementation of Quality System procedures necessary for the efficient operation of the local quality system, ensuring their compliance with regulatory and corporate requirements as well as industry best practices.Acting as Deputy Management Representative for the Brea site. Taking the lead Role in external audits. Ensure site is in a state of audit-readiness.Facilitating Quality System Management Reviews (QSMR) for the site. Ensuring timely submission of quality data and escalation of trends for CAPA consideration.Maintaining a strong on-going knowledge of latest agency regulatory requirements (e.g. US FDA, China FDA, Health Canada, HPRA guidance, JPAL, IVDD, IVDR, TGA, ANVISA) and applicable standard requirements (e.g. ISO 13485)Managing the Brea CAPA (corrective and preventive action) process, including training & mentoring on the CAPA process.Responsible for 4 direct reports in quality assurance / quality control. Aligning on performance and development goals, reporting performance.Overseeing local site quality processes including incoming/outgoing inspections, calibration, product non-conformances, process and non-product software validations. Show less

Brea, California, United States

Reviewed CAPA Requests / data sources and determined whether the document meets the criteria for initiating a CAPA. Assembled the CAPA Review Board (CRB) to audit in making CAPA decisions.Responsible to ensure overall effectiveness of the CAPA process for the Brea site. Escalated CAPA resource allocation needs to site / business management.Reported on time delivery to CAPA owners and management monthly.Mentored CAPA owners on the CAPA process and completion of… Show more Reviewed CAPA Requests / data sources and determined whether the document meets the criteria for initiating a CAPA. Assembled the CAPA Review Board (CRB) to audit in making CAPA decisions.Responsible to ensure overall effectiveness of the CAPA process for the Brea site. Escalated CAPA resource allocation needs to site / business management.Reported on time delivery to CAPA owners and management monthly.Mentored CAPA owners on the CAPA process and completion of documentation.Reviewed and approved CAPA records to ensure compliance with applicable procedures and standards.Presented CAPA records and processes to internal and external auditors.Local process owner of Internal Audits. Created and maintained the internal audit schedule for the Brea site. Planning and performing internal quality audits internal audits as a lead auditor (ISO 13485 / 9001). Reviewing and approving internal audit finding responses and correction/corrective action implementation. Show less

Brea, California, United States

Management of Supplier Corrective Action Requests (SCAR).Local process owner of purchasing controls for both Brea and Carlsbad, CA sites.Planning and performing quality audits of suppliers and internal audits as a lead auditor (ISO 13485 / 9001)Front room support of internal and external audits (including MDSAP) as a SME in purchasing controls.Monitoring and reporting of supplier quality metrics to the L2/L3 level and at QSMR.Leading cross-functional problem solving (PSP)… Show more Management of Supplier Corrective Action Requests (SCAR).Local process owner of purchasing controls for both Brea and Carlsbad, CA sites.Planning and performing quality audits of suppliers and internal audits as a lead auditor (ISO 13485 / 9001)Front room support of internal and external audits (including MDSAP) as a SME in purchasing controls.Monitoring and reporting of supplier quality metrics to the L2/L3 level and at QSMR.Leading cross-functional problem solving (PSP) teams for red or un-favorably trending metrics. Assembling and leading cross-functional teams for the supplier selection and supplier change notification processes.Aid in making CAPA decisions as a member of CAPA review board (CRB) for Brea/Carlsbad sites.Originating and presenting CAPA requests to CRB.Provides mentoring/coaching to other supplier quality engineers and procurement on properly executing procedure and work instruction requirements.Facilitation of local and global Kaizen teams as a certified practitioner in Transactional Process Improvement (TPI) Show less

Corona, California, United States

Development and leading of critical timelines for process transfers, equipment transfers, and improvement projects Participating on corrective and preventive action (CAPA) teamsSupporting customer audits and internal auditsKnowing and adhering to ISO 9001/13485 regulationsWriting and executing process validation (IQ, OQ, PQ) including development of statistical rationaleFailure Investigation and root cause determination