Jonathan Mcvay Email and Phone Number
As an accomplished senior-level quality manager and client-facing leader, I specialize in steering large-scale quality operations for massive, multimillion-dollar sites and ensuring strict compliance in highly regulated environments within the medical device and pharmaceutical spaces. My background includes experience in developing quality systems and revamping processes to optimize production quality while meeting critical customer requirements and timelines, generating savings, and mitigating risk. I believe that a strong workforce is critical to business success, and I excel at restructuring and guiding teams to maximize overall performance, ensuring scalability with demand to enable the delivery of safe, efficacious products globally.I also bring to the table extensive customer-facing experience, serving as the go-to source for inquiries and site inspections while maintaining strategic, trusting partnerships that benefit all parties. Earlier in my career, I gained valuable exposure to FDA regulations via multiple notified body and non-regulatory audits, which has been essential in earning a record of successful site audit representation.**HIGHLIGHTS**➺ Significantly optimized product quality, strengthened team performance, and minimized risk at Flex through spearheading large-scale team restructures and enhancing the workplace culture.➺ Appointed to serve as Flex’s Chicago site Management Representative, assuming oversight to ensure adherence to quality system requirements, conducting quality reviews, reporting on performance, defining a quality plan, and establishing quality system procedures.➺ Played a major role in yielding significant ROI across five years for Oklahoma Blood Institute after designing and implementing a process improvement initiative. Generated major yearly savings by creating lab functions in-house, including creating processes, hiring staff, and acquiring equipment.**EXPERTISE**Quality Control, Quality Assurance, Business Unit Transformations, Continuous Process Improvement, Product Management, Client & Supplier Relations, Quality Planning, Risk Mitigation, Validation Protocols, Audits, Project Management & Delivery, Supply Chain Management, Regulatory Compliance, Team Building & Leadership, Inspections, Training, Laboratory Operations, Manufacturing, cGXP & Medical Device RegulationsISO 13485, FDA 21 CFR 820, cGMP, EU MDR, GXPs, ISO 9001, ISO 14971, ISO 14001, FDA 21 CFR 211, ISO 14031, ISO 11737-1, ISO 14644-1, ISO 14698-1
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Site Head Of QualityFlex Jan 2024 - PresentAustin, Texas, United States
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Director Of Quality AssuranceFlex Aug 2022 - Jan 2024Buffalo Grove, Illinois, United StatesRecruited to provide quality-focused leadership across Flex’s massive flagship health solutions location, I serve as the customer-facing rep for several essential interactions and inspections within the site. My scope of responsibility includes contributing to defining QMS strategy while managing an 80-member quality team and ensuring robust document control, team training, audit management, supplier quality, lab testing, investigations, and internal audits.**HIGHLIGHTS**➺… Show more Recruited to provide quality-focused leadership across Flex’s massive flagship health solutions location, I serve as the customer-facing rep for several essential interactions and inspections within the site. My scope of responsibility includes contributing to defining QMS strategy while managing an 80-member quality team and ensuring robust document control, team training, audit management, supplier quality, lab testing, investigations, and internal audits.**HIGHLIGHTS**➺ Turned around customer score card results with a 56+-point improvement within a three-month period via revising processes and developing staff, including managers. ➺ Achieved zero findings (non-conformances) in a 2/2023 notified body audit, serving as the front room host and lead auditor.➺ Transformed and recovered a strategic relationship with a key, billion-dollar customer by nurturing client-facing relations, as well as carefully identifying and responding to their needs.➺ Navigated the site through various challenging periods from a quality perspective, such as a mold cavity issue, Christmas environmental excursion, and SQIP, resulting in a release of stop-ship and disposition of millions of dollars in product.➺ Successfully mitigated a stop-ship by resolving material control issue on the production of 200,000 units per day. Additionally cleaned up all non-conforming materials within a two-day period.➺ Enhanced customer satisfaction, facilitating future success, via leveraging first-hand knowledge of BFG site expectations, gathering site needs, and building relationships with site SLT. Show less
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Site Head Of QualityBd Feb 2022 - Aug 2022Mannford, Oklahoma, United StatesFollowing a promotion, I led quality functions at a facility with millions in production value of class II single-use disposable, durable medical devices, with 280 SKUs and 2.5 million units produced annually across various methods and technologies. As part of this role, I developed and led a 25-member quality team, in addition to overseeing product, systems, and new product management functions. Ensuring adherence to FDA, European, and global regulations/standards also fell under my control… Show more Following a promotion, I led quality functions at a facility with millions in production value of class II single-use disposable, durable medical devices, with 280 SKUs and 2.5 million units produced annually across various methods and technologies. As part of this role, I developed and led a 25-member quality team, in addition to overseeing product, systems, and new product management functions. Ensuring adherence to FDA, European, and global regulations/standards also fell under my control. **HIGHLIGHTS**➺ Turned around a site risk classification rating from “high risk” in 2019 to “medium/low risk” in 2022 after leading the quality team in hosting a corporate audit assessment.➺ Designated as Management Representative to lead quality programs, continuous improvement efforts, and quality system site functions.➺ Seamlessly assumed the HOD quality leadership role while advancing team and site performance.➺ Enabled business continuity by establishing a team and initiating activities to comply with EU MDR requirements. Show less -
Quality Systems Manager & Quality Assurance SupervisorBd Aug 2020 - Aug 2022Mannford, Oklahoma, United States**HIGHLIGHTS**➺ Promoted to lead a 15-member quality systems team while managing the site’s transition to a new legal manufacturer. ➺ Spearheaded the site’s integration of QMS into a globally harmonized quality system.➺ Enabled the passing of several notified body, corporate, and internal audits after overhauling and reimplementing multiple quality systems, such as document control, non-conformance, and training systems.➺ Structured a top-performing team adept at… Show more **HIGHLIGHTS**➺ Promoted to lead a 15-member quality systems team while managing the site’s transition to a new legal manufacturer. ➺ Spearheaded the site’s integration of QMS into a globally harmonized quality system.➺ Enabled the passing of several notified body, corporate, and internal audits after overhauling and reimplementing multiple quality systems, such as document control, non-conformance, and training systems.➺ Structured a top-performing team adept at responding to business needs, driving positive cultural change, and mitigating site risk; played a role in positioning several team members for leadership roles. Show less
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Quality Engineer I, Ii, IiiBd Aug 2017 - Aug 2020Mannford, Ok**HIGHLIGHTS**➺ Conducted numerous supplier audits, developed equipment validation plans, and created lab procedures.➺ Led the front room for 3rd-party, internal, and corporate audits, as well as the back room for a 2018 FDA audit.➺ Optimized operations by redesigning processes and procedures for sterile release, training, and document control.
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Quality Coordinator, Donor ServicesOklahoma Blood Institute Aug 2010 - Jan 2014Okc, Ok**HIGHLIGHTS**➺ Liaised between OBI executive management and outside regulatory agencies.➺ Constructed root cause corrective action plans for all external (FDA, AABB, state regulatory agencies) and internal assessment findings, in addition to FDA near-miss and reportable errors.➺ Served as a front room audit participant for more than five FDA and 20+ internal audits. -
Laboratory Supervisor, Platelet ManufacturingOklahoma Blood Institute Aug 2008 - Aug 2010Okc, Ok**HIGHLIGHTS**➺ Served as SME on all SOPs regarding apheresis platelet products. Trained all new hires on product manufacturing.➺ Created a new process for the manufacture of apheresis platelet products, enabling OBI to achieve unprecedented success in the development of FDA-compliant products.➺ Developed and guided a six-member team in the manufacture of products, ensuring product safety, purity, and potency.
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Quality Control TechnicianOklahoma Blood Institute Jul 2007 - Aug 2008Okc, Ok
Jonathan Mcvay Education Details
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Chemical Engineering -
B.S. Biochemistry
Frequently Asked Questions about Jonathan Mcvay
What company does Jonathan Mcvay work for?
Jonathan Mcvay works for Flex
What is Jonathan Mcvay's role at the current company?
Jonathan Mcvay's current role is Senior-Level Quality Director ✶ Large-Scale Site Quality & Compliance Manager ✶ Team Building & Leadership Strategist ✶ FDA, Notified Body, and Non-Regulatory Audit Specialist ✶ Customer-Facing Site Rep.
What schools did Jonathan Mcvay attend?
Jonathan Mcvay attended University Of Oklahoma, University Of Oklahoma, University Of Chicago.
Who are Jonathan Mcvay's colleagues?
Jonathan Mcvay's colleagues are Max Dubov, Jayaraj Jr, Laura Esquivel, Devika Adithan, Adriano Santos, Yuji Suzuki, Margaret Bittorf.
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