Jonathan Mcvay Email & Phone Number

Austin, Texas, United States

Buffalo Grove, Illinois, United States

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**➺… 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

Mannford, Oklahoma, United States

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… 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

Mannford, 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

Mannford, 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.

Okc, 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.

Okc, 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.

Okc, Ok

B.S. Chemical Engineering, Chemical Engineering

B.S. Biochemistry

Education record