Joseph T Cook Email & Phone Number

Wayne, Pa, Us

Franklin Lakes, New Jersey, Us

Senior Quality Manager • Responsible for all aspects of managing operational quality for a manufacturing plant. • Lead plant quality team of 18 associates. • Quality management representative. • Responsible for initiatives that improved compliance at the operation resulting in zero FDA observations for the operations during the last 2 FDA audits (2018 and 2023). • Responsible for successful transition to ISO 13485:2016. Transition audit had zero audit findings. • Ensured compliance of the operation to external standards/regulations. • Drove initiative to improve product quality resulting in an 80% reduction in product nonconformancies and a 70% reduction in complaints. • Managed all quality aspects of moving the operation to a new building. Implementation and validation of a semiautomated and 2 highly automated manufacturing lines was included in this move. Move required a PMA supplement as the some of the product lines being moved were class III. • Managed all quality aspects of transfer of an additional product family to the plant. Implementation included a high speed automated manufacturing line, a formulation cell and steam autoclaves. • Member of a core working team for the restructure of the Corporate Quality System. • Member of team that redefined the global quality system documentation for auditing, CAPA, nonconformance and planned deviation.• Facility/operation received the Fiscal Year 2018 H.P. Becton Award – Special Recognition Award. Awarded in recognition of successful improvements in root cause assessments and corrections to reduce complaint and product nonconformancy rates. • Facility/operation received the Fiscal Year 2018 Diagnostic Systems Presidents Award for Operational Excellence.

Newark, Delaware, Us

Provided Quality support for multiple divisional support groups. Provided Quality support for implementation of divisional software systems (e.g: configuration management, complaint processing, device tracking). Served as the primary regulatory contact for the supported groups. Ensured compliance of the supported groups to internal and external standards/regulations, ensuring divisional consistency amongst the groups. Involved in processing and executing divisional CAPA activities. Member of the divisional audit team.

Newark, Delaware, Us

Performed sterilization validations and developed new sterilization processes for the Medical Products Division (Ethylene Oxide, Gamma and Steam). Provided sterilization validation support for nine (9) facilities. Defended sterilization validation activities to regulatory agencies. Reviewed, assessed, developed and validated new sterilization methodologies needed to support ongoing business and technical needs. Assisted in the preparation of the sterilization validation sections of multiple regulatory submissions (PMAs and 510(k)s). Participated in multiple design teams to ensure sterilization requirements for the projects were properly addressed. Reviewed and assessed sterilization processes to ensure business needs are met. Member of the divisional internal, supplier and clinical study audit teams. Member of the divisional Product Life Cycle Management software implementation team.

Newark, Delaware, Us

Led Quality Assurance activities at the Sunnyvale facility. Served as the facility Management Representative. Successfully lead the preparation of the facility for FDA site inspections related to PMA submissions. Assisted in the preparation of regulatory filings. Ensured that the quality system was adequate and properly implemented to ensure compliance to 21CFR 820, ISO 9001 and ISO 13485. Responsible for Environmental Monitoring activities and cleanroom validations.

Managed all Quality functions including: Provided Leadership, managed a quality grouped consisting of 3 employees, Quality Control operations, ISO 9001 compliance, internal and external auditing, personnel training, change control, training, design review, failure analysis management, documentation review, documentation revision/development, development of Quality metrics, and Quality data trending and reporting. Corporate ISO 9000 Management representative.

Managed all Plant Services functions (Quality, Production Control, Information Technologies). Provided leadership and managed the Quality and Plant services group of 2 employees. Assisted Operations in implementing Market Rate of Demand processes. Assisted Operations in implementing procedures that resulted in a 58% reduction in inventory and an increase in on-time deliveries to 98%. Responsible for all issues related to ISO 9001. Performed all Information Technologies functions. Provided ERP software support and installation.

Developed, implemented and managed the Company Wide Quality Program to ensure compliance with ISO 9001 and FDA cGMPs. Managed all Quality Assurance, Quality Control (visual and mechanical inspections), Metrology and Document Control functions. Performed employee training. Developed and implemented the Document Management System including all Document Control systems and procedures. Provided leadership and managed 2 employees.

Assisted in the maintenance of the Company Wide Quality Assurance Program. Performed and led Quality System audits to ensure compliance with ISO 9001 and FDA cGMPs. Developed systems to ensure compliance with ISO 9001. Performed sterilization validation of Ethylene Oxide sterilization processes. Coordinated and supervised new material qualifications. Performed employee training and product complaint processing. Developed and implemented a supplier qualification and certification program. Hired to address FDA 483 and Warning Letter findings.

Maintained compliance with sterility regulations. Monitored and maintained production cleanroom certification. Assisted in the maintenance of the Company Wide Quality Assurance Program. Performed and led internal and supplier Quality System audits to ensure compliance with ISO 9001, ISO 9002 and FDA cGMPs. Implemented and operated microbiology laboratory. Performed hazardous materials coordination. Supervised Quality Assurance functions and personnel within an environmentally controlled packaging area. Performed process and new product sterilization validation using Gamma and Steam sterilization. Devised and implemented software verification and validation studies per ISO 9000-3 to support 510(k) regulatory submittal and approval.

Developer and Manufacturer of Class I and II implantable medical devices.); Assisted in the implementation of the Company Wide Quality Assurance Program. Lead auditor and audit team member of audits to ensure internal and vendor compliance to FDA cGMPs. Performed Ethylene Oxide sterilization process validations and new product sterility assurance validation. Performed personnel training. Installed and serviced company personal computers and Local Area Network. Assisted in software and hardware purchasing decisions. Developed and coordinated equipment validations and qualifications to ensure regulatory compliance.

Ba, Biology (Microbiology And Genetics)

Education record

Education record