J-Pac Medical has a 40-year track record as a medical device contract manufacturing company building industry partnerships based on trust, transparency, technical expertise and quality work above all else.
To learn more about our journey to becoming the unique full-service medical device contract manufacturer we are today, read our company history here.
Quality is our hallmark
J-Pac Medical is uncompromising in its commitment to quality, from the quality systems in place across our U.S. and Costa Rica facilities to the individual ownership our employees take over our quality procedures every day.
We demonstrate this commitment through:
- Maintaining FDA registration as a Medical Device Manufacturer (#1221051), including bi-annual FDA audits
- Annual ISO 13485 surveillance audits and full Quality Management System certification through the British Standards Institute (BSI)
- Frequent third-party and customer quality system audits
- Monthly non-viable testing, daily differential pressure monitoring and quarterly viable testing
- Lot traceability to suppliers’ raw material lot numbers through our ERP system
- Controlled labeling process and a dedicated secure room
- Lot release, including sterilization release
In addition, we utilize automated Quality System software and an enterprise resource planning (ERP) system to ensure precise inventory control, production scheduling, quality control and financial reporting.
70,000 square feet of dedicated medical device manufacturing and packaging space
With state-of-the-art facilities in Somersworth, New Hampshire and Costa Rica, J-Pac Medical supports 70,000 total square feet of dedicated medical device manufacturing, assembly and packaging space.
These sites include 12 total Class 7 and 8 cleanrooms, including a Class 7 dry room. Within these rooms are spaces dedicated to low-humidity manufacturing and solvent scouring for careful handling of bioabsorbable polymers.
Each site also features warehouse space with multiple shipping and receiving bays for flexible raw material and finished product staging.
In-house tooling center reduces costs and timelines
An extensive tool room in our Somersworth facility enables the rapid development of custom tooling for nearly every medical device and diagnostic application.
Our ownership of precision machinery supporting the fabrication of unique, custom tools means your custom requirement will be met with reduced time to market, increased program efficiency and the burden of equipment investment off your shoulders.
On-site labs streamline engineering, prototyping, testing and quality control
Product engineering and on-site quick-turn prototyping are available with in-house laboratory spaces where our team develops the validated processes you require to launch your product on the market.
In our quality control lab, trained inspectors monitor incoming components, in-process assemblies and final product releases.
In-house EtO sterilization for engineering and initial production scale-up
By offering medical device sterilization services in-house, J-Pac Medical saves you time by keeping more pre-commercial functions under one roof.
We also offer contract EtO sterilization services for small lot sizes or higher volumes of smaller parts, further streamlining your program as it scales to meet growing demand.
J-Pac Medical’s management team is committed to building true partnerships based on transparency bringing a wide range of technical and management experience to bear on every project we take on.
Phil Littlefield has an extensive manufacturing operations and engineering background, with an emphasis on business development and capacity growth in diverse FDA-regulated industries, as well as the development and implementation of FDA-compliant ISO 13485/ISO 9001 business operating systems. In his role at J-Pac, he utilizes his manufacturing and supply chain expertise to leverage J-Pac’s capabilities and emphasize continuous improvement and best-in-class operating systems.
Littlefield also leads the New Product Development team as well as the Project Management Program at J-Pac Medical. Under his leadership and mentorship, J-Pac Medical provides innovative solutions to customers’ packaging challenges, and ensures speed-to-market along with comprehensive regulatory testing and compliance services with our customers’ new product launches and existing package revisions.
Littlefield is a performance-driven operations leader with demonstrated success delivering superior results in Lean/Six Sigma manufacturing, global supply chain and logistics management, and organizational development.
Littlefield holds a Bachelor’s in Civil Engineering from the United States Coast Guard Academy. He is a recipient of the President’s Award for Plant Safety, as well as Most Overall Improved Plant Award winner.
Michael Dolge brings more than 20 years of international management and financial experience to J-Pac Medical.
Prior to joining J-Pac Medical, Dolge served as CFO at GI Supply Inc., a distributor of endoscopic medical devices serving leading medical centers, hospitals, and physician offices. Dolge has also held senior positions at multi-billion dollar, publicly traded companies such as Rohm and Haas and the Industrial Products Division of Goodrich, as well as management positions with Johnson & Johnson in operational finance. Prior to J&J, Dolge was a senior auditor with Deloitte and Touche.
Dolge holds a Bachelor’s in Accounting, Cum Laude, from Villanova University and is a Certified Public Accountant in the Commonwealth of Pennsylvania.
As the Director of Regulatory and Quality Assurance at J-Pac Medical, Toni McBride leads the development, management, implementation and sustainability of our ISO 13485:2016 Quality Management System, and ensures the effective implementation of those standards across the entire organization.
McBride also directs the effective implementation and execution of all quality assurance and improvement activities in compliance with J-Pac’s FDA registration under 21CFR Part 820 , including the recent implementation of J-Pac’s comprehensive electronic quality management system (eQMS) which linked all of J-Pac’s critical-to-quality functions though a comprehensive cloud-based control system.
In addition, McBride also oversees J-Pac’s global regulatory compliance program and safety and risk management programs across the organization.
Most recently, McBride spearheaded the qualification and validation of J-Pac’s in-house ethylene oxide (EtO) sterilization system, providing our customers a complete validated turnkey packaging solution from packaging design through sterilization and release
Toni McBride has over 25 years of operational and quality assurance expertise in the medical device industry, ranging from Manufacturing Manager to her current Director role with J-Pac Medical. Her comprehensive, hands-on expertise with the entire value stream creates a top-down total employee engagement with the quality management system, and ensures that J-Pac delivers exceptional products and services to our customers and their patients, each and every time.