Quality & Auditing Expert
Senior Consultant
Tim joined Qserve in 2022 as a U.S. Associate with more than 20 years of experience in the medical device and pharmaceutical industries.
Tim’s experience includes designing, implementing, and improving quality systems, auditing to domestic and international regulations, and product design assessments and reviews. Additionally, Tim holds a degree in Microbiology and certifications in Lean Six Sigma Yellow Belt and Certified Quality Auditor.
Tim about working at Qserve
The quality of consumer products and how products are made has always been a passion of mine. That passion has evolved over the course of my education and career to become building quality management systems and products that not only ensure the safety of patients but also minimize risk to the company shareholders and ensure the overall success of the company. Qserve is an industry leader in the medical device arena and all things quality and regulatory. Being a part of the Qserve team offers me the ability to further my expertise on medical devices, quality management systems, and regulatory affairs and feed my passion for ensuring the quality of consumer products.
Before Qserve
As a Senior Consultant, Tim designed and implemented multiple quality management systems for medical device organizations to meet domestic and international requirements, developed strategies and received marketing clearance on multiple medical devices of all classes and classifications, and performed internal, supplier, and mock audits to domestic and international regulations.
Within the industry, Tim was responsible for developing the quality and regulatory strategy for global manufacturers and contract manufacturers. Along with developing the quality system to support a company’s international growth, Tim has been responsible for all quality functions and personnel within a global organization. Tim has directly managed the design and development of Class I, II, and III medical devices including sterile, implantable, surgical, combination, and over-the-counter products.
The key expertise areas of Tim:
- Quality Assurance and Regulatory Affairs throughout all stages of the Medical Device lifecycle
- Expertise in the design, implementation, monitoring, and maintenance of Quality Management Systems according to ISO 13485, MDSAP, MDR, and other relevant regulatory requirements
- Inspection Readiness focused preparation approaches; remediation of 483s and non-conformities; advice on the process of hosting audits/ inspections
- Expert advice and training on the interpretation of the Medical Device Directives, EU Medical Device Regulation, MDSAP (US, Canada, Japan, Brazil, Australia), and other country regulations pertaining to medical devices
- Performing internal quality system and supplier audits (9001, 13485, MDSAP, MDR, country-specific) as Lead Auditor. Extended experience in audit preparation and performance, gap assessments, and mock audits.
- Expertise in Design Control system design, implementation, and management.
- Advice on Design History Files, Device Master Records, and Product Design Dossier / Technical Files including gap assessments to applicable regulations.
- Expert advice on selection, process, and preparation of a new Notified Body (initial certification and transfers)
- Risk Management expertise including the development and implementation of a risk management process
- Software as a Medical Device and software validation review and submission readiness assessments.
- Expert advice regarding EO and irradiation sterilization according to ISO 11135 and ISO 11137
- Expertise in CAPA system design, improvement, and management
- Software as a Medical Device and software validation review and submission readiness assessments.
- Expertise in CAPA system design, improvement, and management
- Inspection Readiness focused preparation approaches; remediation of 483s and non-conformities; advice on the process of hosting audits/ inspections