Joe Sinclair Email & Phone Number

Vancouver, Washington, United States

Portland, Oregon, United States

- Design and implement the quality management system for ISO13485 / FDA 21 Part 820, and ISO9001.- Direct efforts for new market entry of wearable medical device, including 510k submission strategy.- Direct both FDA and ISO 13485 regulatory strategy to support business objectives.- Direct the Quality Management Review process, including oversight of analysis and reporting of Quality System performance metrics.- Plan, lead, and execute all internal and external audits, including supplier qualification.- CAPA design and management including complaint handling and risk management.- NCMR system implementation and continuous improvement.- Design and implement quality control systems for manufacturing.- Manage cross-functional Quality Control team including quality engineering, manufacturing development, electrical and mechanical engineering, software development, sales and executive leadership.- Oversee key procedural development for scalable production of complex gallium based metal gel.- Clinical study development and approval through IRB process with Northwell Health and Mount Sinai Health System. - Member of IPC standard review team for electronics manufacturing.

Oregon City, Or

- Lead team of 35+ employees to address compliance failures using corrective and preventative actions. - Perform Quality Control and Quality Assurance to support ISO 13485:2016 and FDA 21 CFR Part 820. - Prepare for and lead audits from external regulatory agencies and customers.- Conduct ongoing analysis of department productivity by applying Lean Manufacturing Methods. - Develop and write departmental SOPs to support customer quality requirements and FDA regulatory demands.- Manage and coach Quality team including HR functions (e.g. hiring and training of new employees, analyzing staff strengths and weaknesses, payroll management). - Meet daily, weekly, and monthly production goals.

Portland, Oregon Area

- Manage quality assurance across six national and international (Netherlands) laboratory sites. - Advise laboratory, donor coordination, and business development department heads on compliance related to regulations, procedures and requirements. - Direct the audit process for regulatory bodies such as FDA, OSHA, AATB, CDC, New York Department of Health, and Oregon Health Authority pertaining to the tissue banking industry. - Maintain AATB site certification for MedCure including audit preparation/response. - Conduct root cause analysis investigation of complaints and incidents to ensure timely resolution. - Optimize laboratory standard operating procedures, compliance, and shipping logistics.

Portand, Or

- Assist with audit prep and passing of American Association of Tissue Banks (AATB) Audit. - Manage daily flow of approvals for human tissue specimen shipments for all MedCure facilities.

Portland, Or

-Assisted with Quality Assurance Process Improvement including audit preparation for American Anatomical Tissue Bank (AATB) certification.-Developed Research and Development program for tissue quality maintenance and preservation – including quality system related chemical requirements.-Procedure and logistics operations optimization.-Managed surgical training and bio-skills courses for medical personnel and medical device clients such as Depuy, Smith and Nephew, Arthrex and Wright Medical.-Human cadaver dissection and specimen preparation for scientific research purposes and surgical training applications.

• Developed and implemented chemistry/wet lab internal procedures and test methods.• Authored customer specific technical reports using standard scientific writing formatting and conventions.• Initiated quality system conforming to ISO 17025 parameters.• Materials Testing (e.g. Microhardness, EDS, Tensile Properties, Viscosity, Taber Abrasion, Metallurgical analysis, Failure analysis).• Responsible for maintenance and use of analytical chemistry instrumentation (e.g. ICP, HPLC, FTIR, GC/MS, AAS, Vis-Spec, Raman Spectrometer, Flourescence Spectrometer).

Seattle, Wa

• Implemented quality systems (ISO 9001, ISO 17025), including writing and applying SOPs.• Coordinated internal audit structure and round robin processes.• Consulted customers regarding implementation and contract review of testing schedules and overall reporting issues.• Performed internal preparation for both Chemical Processing and Materials Testing NADCAP audits.• Trained new and existing employees in laboratory procedures and Quality Systems compliance.• Maintained external instrument calibration schedule and performed internal calibration of Pyrometry, Corrosion and Taber Abrasion instrumentation.

Seattle, Wa

• Managed Pyrometric Testing program (e.g. large oven temperature uniformity surveys, system accuracy testing per AMS 2750)• Titration analyses (e.g. Acid/Base, Indicator, EDTA, Silver Nitrate, pH Electrometric, Sodium Thiosulphate),• Heavy metals testing using ICP-AES/ICP-MS instrumentation.• Performed wastewater digestions using Aqua Regia.• HPLC testing for ion contaminant concentrations.• Performed Total Dissolved Solids testing.• Distillation of Penetrant oil solution for water content.• Oversaw corrosion testing for Salt-Fog and High Humidity instrumentation.• Tensile testing on various metal alloys and coatings using Notch Tensile and Bond Strength specimens.• Metallurgical testing for sample preparation and hardness (e.g. Knoop, Vickers, Rockwell).• Tabor Abrasion testing on material specimens.

Bachelor Of Science (Bs), Chemistry

Bachelor Of Science (Bs), Biology, General