Quality &
Certification

Sterling Industries, quality management and ISO standards
Good business is all about trust: customers trusting that their expectations will be met, that companies stand behind their products, and that individuals work with integrity and care. At Sterling, quality management and ISO standards are crucial systems for building and ensuring our clients’ trust.

At Sterling, we understand the life-changing potential of the medical devices, equipment and instruments that we manufacture; we also fully embrace the strict, regulatory environments in which they are designed, manufactured and used. Repeatable quality is the key to success, both our clients’ and our own. That’s why we’ve built our entire business around a rigorous and sophisticated Quality Management System, fully integrated into our ERP software with production and change control management, with complete electronic document control.  

Our quality assurance process includes a full control plan for Receiving, In-Process and Final Product inspections, and we have a rigorous Product Part Approval Process (PPAP) and First Article (FA) process for new products.

Lastly, our packaging and labelling process is fully integrated into our state-of-the-art ERP system, allowing us to provide our clients with full Serialization and Lot Control tracking.

It all works together to ensure that our clients’ Class I, II & III Medical Devices meet all regulatory requirements, every time. It’s one of the key advantages of working with an experienced contract assembler and manufacturer that specializes in delivering finished and compliant medical devices.

ISO 13485:2016 registered view;
C-TPAT and 21 CFR part 820 compliant; FDA and Health Canada registered facilities

Continuous training and procedural improvement of all our staff to consistently reinforce our Total Quality Environment (TQE)

Continuous Improvement (CI) initiatives in every facet of our organization; Six Sigma certified staff, 5S initiatives

A team of Quality Engineers and Quality Inspectors involved at every step throughout the medical device manufacturing life-cycle

Implementation of new products and revision changes through the First Article (FA) process or Production Part Approval Process (PPAP)

Complete validation of equipment through Installation Qualification (IQ), Operational Qualification (OQ) and Performance Qualification (PQ)

Integrated ERP / MRP / QMS systems for production and change control management

Complete control plans and utilization of Statistical Process Control (SPC)

Advanced metrology capabilities including CMM, Vision Sytems, Optical Comparators, and high precision optical 3D micro measurements.

About Us
 

Process &
Design

Sterling Industries Medical Device Manufacturing & Assembly

Manufacturing
& Assembly

Sterling Industries | Medical Device Portfolio

Portfolio & Expertise

Dale Morgan, Director of Global Quality at Sterling Industries

Dale Morgan

Director of Global Quality

Dale is our Director of Global Quality. He brings a career’s worth of experience and leadership in Medical Devices, with deep expertise in quality management systems, regulatory submissions, quality engineering, and more.  Dale has worked with both established medical device OEMs and start-ups, as well as product certification and audit organizations. A licensed professional biomedical engineer, Dale is also certified as an ISO 13485 auditor/MDSAP.

Tim Doyle | Quality Manager, U.S. Operations

Tim Doyle

Quality Manager, U.S. Operations

As Quality Manager of our U.S. Operations, Tim brings over 30 years of experience in computer-aided surgical devices, electromechanical devices, metal fabrication and assembly processes, including clean room assembly and packaging for sterilization. He has extensive international experience, partnering on quality and supplier development projects. Tim holds the ASQ CQE designation. He also proudly served 7 years in the United States Air Force.

Patrick Tam | Quality Manager, Canadian Operations

Patrick Tam

Quality Manager, Canadian Operations​

Patrick serves as Sterling’s Quality Manager, bringing over 20 years of Quality Systems Management experience in the Medical Device and Pharma industries. He leads our Quality Management proactive, bringing a tactical and strategic focus to ensure consistent, repeatable quality for our clients. Prior to joining Sterling, Patrick served as Quality System Manager at Integra LifeSciences where he was responsible for maintaining Quality in their Canadian operations.

Jeff Kiel | Manager, Engineered Solutions

Jeff Kiel

Director of Engineered Solutions

Jeff serves as Director of Engineered Solutions. He works closely with clients to evolve and refine their Medical Device designs — sometimes from the idea stage — through to a fully-optimized, scaleable, ready-to-ship product. He uses his engineering and technical expertise to design our production processes. Prior to joining Sterling, Jeff worked with Toyota in their Prototype Weld Group.

Libni Cano is our Toronto operations’ Regulatory and Quality Manager, responsible for quality and regulatory.

Libni Cano

Regulatory and Quality Systems Manager​

Libni serves as Regulatory and Quality Manager for Sterling’s Canadian sites, responsible for both quality and regulatory compliance. She has over 14 years of experience in medical device quality management systems, with expertise in FDA and Health Canada regulations as well as electronic QMS implementation. Libni is a BSI-certified Lead Auditor for ISO 13485:2016.; she is also ASQ certified with CQE and CMQ designations, and holds a BSc in Industrial and Systems Engineering.

Ronitt is our Director of Business Development with 25 years of experience, and is responsible for Sterling Industries' global business development.

Ronitt Katz

Director of Business Development

Ronitt serves as Sterling’s Director of Business Development, bringing 25 years of experience. She has an extensive background in the tech industry, having worked for IBM, TIBCO and several software companies, from startups to industry leaders. Within the Medtech space, She has vast experience in partnering with Fortune 100 organizations, early stage startups, and everything in between.

Jojo Wang is our Engineering Manager, responsible for leading our Sterling Engineering Team.

Jojo Wang

Director of Engineering

As Director of Engineering, Jojo is responsible for leading the Engineering Team. She brings a wealth of experience in Project Management, Lean Manufacturing, and Product Development, and expertise in designing manufacturing solutions and driving business improvements. Prior to joining Sterling, Jojo served as a process engineering leader for Boston Scientific, focused on electrophysiology solutions. She holds a BSc in Mechatronic Engineering & Automation, and a Masters in Engineering Management.

Lilian So is the Director of Finance here at Sterling Industries.

Lilian Soo

Director of Finance & HR

Lilian is the Director of Finance & HR at Sterling. She is a seasoned professional with over 15 years of progressive experience in Finance, and a talented CPA/CGA who unites operations with finance continuously improving company performance. She has extensive experience with fast paced environment, driving innovations and process improvements to help drive positive changes and optimize profitability.

John Pleskina is the Director of Global Operations for all our facilities, responsible for manufacturing operations.

John Pleskina

Director of Global Operations

John is the Director of Global Operations for Sterling, responsible for manufacturing operations. John has over 25 years manufacturing experience in a variety of leadership roles, most recently as VP of Manufacturing at Southmedic Inc.  Previously, John was Director of Operations for Scapa Healthcare where he was responsible for the effective operation of sites in Canada, the U.S. and the U.K.  A graduate of the University of Waterloo, John served over 14 years with the Royal Canadian Navy.

David Van Slingerland, CEO of Sterling Industries

David Van Slingerland

CEO

David assumed the role of CEO in 2007 and has led Sterling Industries through transformative growth. He brings over 30 years of executive experience, with deep expertise in change management and growing organizations through innovative technology and human capital. At Sterling, he has introduced an agile manufacturing model, built an industry-savvy leadership team, and is responsible for driving customer-focused end-to-end solutions. Prior to Sterling Industries, David held a variety of executive positions with Manulife Financial and Shoppers Drug Mart.