David Matheus Email & Phone Number

Taunton, MA, US

Cambridge, Massachusetts, US

Directed Market Action, Escalation processes, and communication with international health authorities, ensuring efficient management and liaison.Managed customer complaints, inquiries, and Supplier Corrective Action Requests (SCARs) within the international framework, aligning with Moderna's standards.Expedited the establishment and refinement of global.

Corning, New York, US

• As a Regional Manager, I defined strategic direction across eight global sites within the Life Sciences and Pharmaceutical divisions with 230+ employees.As the quality lead, I drove four large acquisitions over four.
• Provided support and guidance for scale up of vaccine vial production from a quality perspective.
• Upgraded the division to ISO 9001:2015 and ISO 13485:2016 to ensure uninterrupted compliance.
• Partnered with business operations and commercial teams to develop plans and visit strategies to retain at risk accounts.
• Interfaced with regulatory team to implement country specific product requirements.
• Developed methods and metrics to evaluate and continuously improve process capability and effectiveness across eight manufacturing and one global distribution site.

Milford, MA, US

• As the Head of Quality Assurance, I drove quality initiatives across four sites with 32 employees. I identified gaps in the global quality system, developed a business enhancement plan, and guided the division upgrade.
• Improved Management and Complaint Reviews to identify and reduce internal and external failures.
• Led 14971 compliant risk management program and implemented a new product development process for the consumable division, which reduced product field failures.
• Spearheaded initiatives to overhaul the CAPA process and integrated formal investigation tools.
• Developed the A3/8D program for structured investigations related to CAPA and process improvements and served as the SME for the post-market surveillance group.

Milford, MA, US

• As the Manager of Post-Market Surveillance, I built processes for the medical device business from the ground up and managed Health Hazard Evaluation, CAPA, NCR, Complaints and Adverse Event reporting. I also built and.
• Coordinated complaint handling staff and led initiatives to improve customer service metrics, which resulted a high quality records and a reduction in complaint closure times.
• Centralized a global complaint management and adverse event reporting process and improved efficiency across the division.
• Served as the medical device quality systems SME for the IVD business.
• Developed and managed the health hazard assessment and field action determination process.
• Implemented a global complaint handling and non-conformance management tool.

Murray Hill, New Jersey, US

• As the Post-Market Surveillance Manager, I championed solutions and revised procedures across CAPA, complaints, adverse events and medical record review. I led lean process initiatives to streamline operations and.
• Coordinated with the FDA and managed a team responsible for reviewing a backlog of thousands of information sources for regulatory reporting, resulting in project completion two months early.
• Developed Global Complaint Handling and adverse event processes to standardize management procedures across four divisions, which improved efficiency.
• Coordinated cross-functionally to develop a system for processing and assessing reusable medical devices to improve traceability, compliance, and throughput.
• Wrote remedial action plans for Post Market product non-conformances, drove HHA reviews to determine necessary field action, and coordinated with the local recall coordinator.
• Served as the Subject Matter Expert for CAPA teams using DMAIC to identify root cause and to develop robust corrective action and VOE plans.

Marlborough, MA, US

• As a Corporate Compliance Lead, I coordinated the global business unit audits and responses for notified bodies and FDA. I also supported global business units and led cross-functional teams in identifying and.
• Drafted responses to the FDA regarding additional information requests, which impacted the lifting of the corporate warning letter.
• Developed a compliance strategy program and internal resource site to provide education for business units, including ISO 13485, MDD, CMDR, RDC59, Min. Ord. 169, 21CFR820.
• Performed Internal Auditor training to PAL and CMDR.
• Served as the SME for Class III devices and the point of contact for the FDA.
• Led a 10-step complaint investigation team to develop a global policy for post market activities.

Marlborough, MA, US

• As an Engineer, I developed protocols, plans, and procedures for testing of returned devices.I managed and approved failure investigations and performed root cause determinations.I also evaluated metrics and.
• Conducted on-site failure and complaint investigations for OEM partners.
• Wrote Health Hazard assessments and Clinical Risk Benefit Analysis documents for Class III products.
• Updated FMEAs based on post market feedback, assessed impact on risk profile and coordinated cross-functionally to develop action plans.

Solon, OH, US

• As a Manager of Quality Assurance, I oversaw quality assurance for the medical device division, provided direction to the organization, and drove department and corporate objectives.I also achieved recognition awards.
• Managed quality staff and all aspects of supplier quality, document control, design, audits, CAPA, complaints, AE reporting, and final inspections.
• Developed a gap analysis and transitioned the quality system to 13485:2003.
• Trained and completed projects using Lean, Kaizen, 5S and Six-Sigma concepts, served as a regulatory resource for the medical device business, and wrote and submitted 510ks.

Bs, Biology

Mba, Global Management