Ruben Perez Email & Phone Number

Westwood, Ma, Us

In this consulting role I provide independent objective advice to medical, life sciences, and pharma organizations on strategies to improve product, system, process, and quality. I also support a diverse groups of clients in implementing quality management systems to prevent compliance gaps (and fix previous deficiencies.) I deliver project management services for tech transfers, QMS implementation, remediation, and certifications. As a sample: • Facilitate full PMO support for manufacturing facility startup planning and management—including production line transfers • Direct preparations for QMS sub-systems remediation (including 483 responses and project planning) • Define supply chain end to end strategy and initiatives to execute in alignment to Corp level objectives • Complete comprehensive GAP analysis and audits of client facilities/suppliers to drive large scale improvements

San Diego, Ca, Us

Oversight of NUVAs manufacturing strategy. Investment of $48M in capital to start up a new 300 employee operation for spinal implants, sterile packaging and additive manufacturing. M&A diligence responsibilities for Global Ops function, integration responsibilities for acquired targets. New product introduction interface between R&D and Ops. Responsible for developing field services infrastructure for Surgical IntelligenceTM and robotics.

San Diego, Ca, Us

Oversight of manufacturing operations for Infusion systems . Operations profile: electromechanical device assembly and test. $200M in supply chain management. Average year over year cost reduction performance of 5%.

Dublin, Oh, Us

Site QA Lead for a $2B medical device business. Key QA leader managing FDA Consent Decree activities, including system development and deployment. Served as Management Representative for San Diego site, engaging in frequent direct interactions with regulatory authorities.

New Brunswick, Nj, Us

Site Quality rep for $4B drug delivery facility. Responsability for QA, CAPA, Stability, Training, and Supplier QA.

Kalamazoo, Mi, Us

Owner for P&L management of $200M business, including vision and long-range strategic planning for Field Services, Technical Support, Customers' Project Management, Pre\Post Sales Engineering, Manufacturing, Supply Chain, & RAQA. Provided cross functional management to 8 Department Heads and general oversight of 200 + employeesBuilt and transfer a $200M business and 100K ft2 facility from California to Texas. Objectives: Identify, negotiate and close new lease in Texas, manage construction, coordinate new IT, furniture requirements, execution strategy and regulatory strategy. Completed the relocation within five months, on time, on budget, with no business interruptions. Management Representative & Compliance Officer

Kalamazoo, Mi, Us

• Responsible for all aspects of manufacturing engineering, new products transfers, cost reduction, electronic services, contract manufacturing and supplier management• Expansion Management – Site Location Executive Responsible for transferring and moving 500 employees to new 165K FT2 facility, on time, on budget with no business interruptions

Kalamazoo, Mi, Us

Mba, Quality Management

B.S., Industrial\Manufacturing Engineering