Joseph Coite Chief Operating Officer (COO) at Dignitana

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Director of Manufacturing & Operations

West Coast Surgical

Jan 2024 - Current (2 years 7 months)

• Responsible for the medical device manufacturing operations at 2 sites. Half Moon Bay, CA and Houston, TX. • Performs internal audits for both sites for FDA and cGMP compliance purposes. • Writes, updates and approves standard operating procedures.

Consultant/Contractor

Oxford Global Resources

Jan 2022 - Jan 2023 (1 year 1 month)

Oxford provides a wide range of consulting in the consumer products, life sciences & healthcare as well as manufacturing industries. • Currently providing project management for Becton Dickenson in a hybrid capacity role. • Responsible for the overall project management for moving a product line including manufacturing, supply chain, RA/QA service repairs, distribution and fulfillment. • Coordinating the efforts of moving manufacturing from the U.S. to Malaysia as well as managing a project team of a dozen people.

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Chief Operating Officer (COO)

Dignitana

Jan 2021 - Jan 2022 (1 year 1 month)

Initially hired as an Operations Optimization Consultant to prevent any possible audit threats of certification removal. • Led the highly successful improvement of existing quality management systems though organizational optimization of a 2020 ISO 13485 audit; ultimately rescuing a total of 10 non-conformances (8 of which were major non-conformances for 2 years prior) within 8 months. • Responsible for the overall improvement of previous supplier relations with contracted providers involving supply chain, manufacturing, and quality issues that lead to increased operational efficiency. • Successfully commenced, managed, and executed the necessary and mandatory product registration for countries located outside of the U.S in order to prop

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Vice President of Operations

Jan 2012 - Jan 2019 (7 years 1 month)

Is an

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Logistics Manager

Modified Polymer Components, Inc. (MPC)

Jan 2011 - Jan 2012 (1 year 1 month)

• Smoothly led the companywide transition to a new, domestic 3PL (third-party logistics) management Great Plains. • Effectively reduced the overall freight costs by 30% through locating new carriers and contract negotiation. • Headed relocation of existing internal warehouse/service department with only one day of downtime and under budget.

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Director of Engineering

Jan 2009 - Jan 2010 (1 year 1 month)

• Responsible for the proper development and implementation of metrics tracking for the engineering department to better trail their on-time deliveries as well as project quality. • Reduced the overall number of NCR's (non-conformance reports) through the improvement of a prevailing 70% product quality score to 90%; ultimately enhancing the on-time delivery rate by more than 35% in just three months. • Served as the lead liaison for all OEM medical device customers; ensured nothing other than satisfactory results.

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Director of Supply Chain

• Managed and oversaw all facets of manufacturing, including distribution, customer service, IT and tech support/repairs. • Oversaw an assortment of direct reports: Directors & Managers belonging to various divisions such as the Supply Chain, Global & Customer Service, International Fulfillment & Repairs, IT, and Medical Billing departments as well as several offsite facilities/distribution/warehousing Facilities. • Daily Officer responsibilities included (but were not limited to) maintaining specific state licensing, financial budgeting & management, as well as participating and (sometimes) leading quarterly Board meetings. • Effectively cross-collaborated with the Engineering and RA/QA (regulatory affairs/quality assurance) teams to s

Consultant

ZOLL MEDICAL CORPORATION

• Managed acquisition & led the transition of Alsius (disposable catheter and capital equipment) from Irvine, CA into the Sunnyvale, CA facility. • Relocated employees to fully close out the Irvine facility as well as integrate and distribute adequate production. • Collaborated with and assisted contractors in the designing, scheduling and completion of company build-out and move-in date ahead of schedule as well as staying within the initial set budget.

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Vice President of Operations

AlterG

Promoted to Vice President of Operations while launching medical grade version of product. • Implemented new policies, procedures and practices in order to move the company from a start-up to the next level. • Designed a part numbering scheme to assist in easy management, tracking and storing of parts. • Created bills of materials to efficiently manufacture end products as well as keep any raw materials, sub-assemblies, intermediate assemblies, sub-components, parts, and the quantities of each highly organized.

Joseph Coite

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