(Startup Company) Developed quality system and tools to support start up, development, and release of medical device first aid kits, OTC Drug products, VMS, and Cosmetics. • SME for Risk Management and HACCP activities. Implemented ISO 14971 and Q9 Quality Risk • Responsible for Post-Market surveillance, complaint investigations, & CAPA• Developed design procedures for medical device, OTC Drugs, VMS, and Cosmetic products• Worked extensively with supplier qualifications, validations, and product conformance with international suppliers• Developed and implemented metrics (Key Process Indicators) and trending• Wrote numerous Procedures, Specifications, Acceptance Criteria, Sampling Plans, Risk Management Files, etc.

Responsible for Post Market Surveillance, CAPA, and Data Analytics for ENT.

• Ensure the products manufactured at US OTC and Device sites meet all relevant quality, safety, and regulatory requirements.• Ensure all operations are supported by compliant and efficient quality systems such that all operations are in a continuous state of control. Anticipate potential problems and put proactive measures in place to prevent them.• Implement quality risk management approaches that are prudent and supported by sound scientific and technical rationales.• Provide quality oversight for the development and commercial stability programs, specifications development and management, and technology transfer of analytical methods from development to site quality control units.• Oversee the QC function, ensuring adequate procedures and full data integrity in all laboratory operations, and a robust talent pipeline in the QC organization.• Champion the quality culture and build outstanding partnerships with operations, supply chain, regulatory, commercial, and other functions based on mutual candor and continual bidirectional learning.• Plan and implement Quality strategies, policies and objectives in accordance with Company strategic plans.• Ensure appropriate quality performance measures are implemented and reported as required.• Prioritize and direct the work of the staff and communicate timetables and standards of excellence regularly to insure commitments are met.• Develop direct reports as ready in place successors.• Design and implement program for sustainment of quality science excellence at all levels of the quality organization.

Same duties as previous Medtronic. Site was part of 17-site divestiture sale of Medtronic to Cardinal Health. Responsible for support of same 6 manufacturing sites.

Manage and direct QA and Compliance personnel at multiple sites for all quality/compliance activities. Led site integration from legacy Covidien to Medtronic policies. Implementation of quality system driving significant improvements in Quality KPI's from 85% negative (red) to over 90% positive (green). Manage site inspections/audits with demonstrated improvement in reducing/eliminating 483s and observed nonconformities. Provide assistance and mentoring to quality managers at sister facilities and facilities within my division.

Responsible for all aspects of Quality Engineering including: product support for outsourced operations, supplier audits, supplier management, supplier corrective action (SCAR), nonconformance disposition (NCR/NCMR), risk assessments, design and process changes, qualifications, validations, verifications, first article inspections, writing/reviewing protocols, sterilization, stability, kaizen continuous improvement projects, metrics and reporting.Also responsible for all aspects of Quality System Compliance including: CAPA management, nonconformance management, deviations, internal audits, external audits, FDA responses and 483 resolutions, Notified Body responses, annual product reviews, assisting regulatory group with MDR/Vigilance, metrics and reporting.

Anything and everything throughout all steps of product realization and support. Manufacturing floor support, issue investigation, CAPA, SQDC, metrics analysis & trending, ECO review, validations & verifications, internal & external audits, kaizen events, calibration remedial action investigations, supplier communication, new product transfer, factory & departmental project support, team leadership & development, and anything else as needed to support achieving the organizational objectives.

Support New Product Development/launch, sustaining products, complaint investigations, CAPA, and internal auditing. Manage document control, receiving inspection, QA Release, and calibration groups.

Oversee all quality and regulatory activities throughout product realization: design, prototype, first article, manufacturing, packaging, sterilization, and distribution. Also responsible for all compliance activities: document control, nonconformance management, CAPA, auditing, 510k submission, Notified Body correspondence, and complaint investigation.